Brinkum/stuhr, Germany

  • Telemedicine for Nonspecific Neck Pain

    Neck pain is a very common public health problem worldwide. It is defined as pain perceived between the upper nuchal line and the spinous process of the first thoracic vertebra. This pain can sometimes be reflected to the head, trunk and upper extremities. Nonspecific neck pain refers to neck pain for which no specific cause or underlying disease can be identified. It is generally used to refer to neck pain that cannot be attributed to conditions such as infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder or radicular symptoms. Although many interventions have been recommended for neck pain in the American Physical Therapy Association (APTA) clinical practice guideline, the only interventions recommended based on strong evidence are coordination, strengthening, endurance exercises, cervical mobilization/manipulation and patient education. Other interventions are based on weak or moderate evidence. In neck pain syndromes, exercise therapy is primarily recommended for neck pain without signs of major structural pathology. In fact, exercise therapy has surpassed physical therapy modalities compared to the past. While exercise, mobilization, and manipulation treatments for non-specific neck pain have the greatest support in the literature, there is little evidence for the effectiveness of thermal treatments and electrical therapies, with no evidence of more than a temporary benefit. This study aims to compare the telemedicine method, in which asynchronous exercise videos (tele-exercise) and educational videos containing recommendations (tele-education) are sent to patients' phones, and patients are followed up by physicians via remote video calls (tele-consultation), with the conventional follow-up method, in which patients are given a brochure containing the same exercises and recommendations, and patients are followed up by physicians via face-to-face meetings in the hospital. Participants will consist of patients diagnosed with non-specific neck pain. Patients will be randomly assigned to one of two groups: Group A (Telemedicine Group) and Group B (Conventional Follow-up Group). The study content will be explained to the patients on the first day at the hospital and they will be asked to sign a voluntary consent form. Patients in Group A will receive a pre-recorded neck exercise video and an educational video sent to their phones by the physician. These patients will exercise at home three times a day for 2 weeks. They will mark the exercise diary provided to them when they do their exercises. They will have remote check-ups via video call every two weeks (on the 15th and 30th days) to monitor pain intensity and provide support. Patients in Group B will receive an exercise brochure and an educational brochure provided by the physician in person at the clinic. These patients will also exercise at home three times a day for 2 weeks. They will mark the exercise diary provided to them when they do their exercises. They will have clinical check-ups every two weeks (on the 15th and 30th days) to monitor pain intensity and provide support. The primary outcome measures are pain intensity measured using the Visual Analog Scale (VAS) and neck function assessed using the Neck Disability Index (NDI). Secondary outcome measures are adherence to the exercise program monitored through an exercise diary, patient satisfaction assessed on a Likert scale from 0 to 5, and total money spent on follow-up visits (transportation expenses, healthcare expenses) and time (time spent on the road, hospital waiting time) for Group B. VAS and NDI will be measured initially for both groups through face-to-face assessments. In 15th day, VAS and NDI will be administered through video interviews (Group A) and face-to-face assessments (Group B). In addition, completed exercise diaries will be collected via WhatsApp (Group A) or clinic visits (Group B), and total money and time spent on transportation will be calculated for Group B. In day 30, VAS, NDI, and patient satisfaction will be assessed through video interviews (Group A) and face-to-face assessments (Group B). Participants will be unaware of the procedures used in the other group and the outcome assessor will be blinded to group assignments during the statistical analysis to prevent bias. Adherence will be monitored through exercise diaries and qualitative feedback will be collected through surveys or interviews to understand patient experiences and compliance difficulties. Sample size will be determined based on power analysis. The primary hypothesis (H1) is that Group A will show greater improvement in pain reduction and neck function than Group B due to the more accurate implementation of video exercises and advice than visual exercises and advice. The secondary hypothesis (H2) is that Group A will show higher adherence and satisfaction due to the ease of video-based exercises and the lack of a hospital visit. This study will be the first scientific study to compare the telemedicine method with the conventional method. If the telemedicine method demonstrates an equivalent or superior efficacy to the conventional method, If the telemedicine method shows an effectiveness equal to or superior to the conventional method and this method is widely used in the future, this will provide great convenience for both clinicians and patients, reduce the density in hospital polyclinics and reduce the risk of contamination in healthcare areas. Telemedicine applications that can be performed remotely in diseases that do not involve serious pathology provide significant advantages to both individuals and health insurance systems in terms of time (time spent on the road, waiting time in the hospital, etc.) and financial expenses (transportation and healthcare expenses, etc.). In addition, these methods reduce air pollution by reducing traffic density and gasoline consumption, thus minimizing environmental impacts. The spread of telemedicine applications also stands out as an effective medical option in unexpected quarantine conditions such as pandemics.

    Phase

    N/A

    Span

    23 weeks

    Sponsor

    Antalya Training and Research Hospital

    Antalya

    Recruiting

    Healthy Volunteers

  • A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

    The purpose of this study is to assess the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm. This study will be conducted at up to 200-250 sites globally in approximately 25 countries.

    Phase

    3

    Span

    298 weeks

    Sponsor

    AstraZeneca

    Antalya

    Recruiting

  • A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure

    The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite of > 50% decline in eGFR, kidney failure, or CV death, in individuals with CKD and HTN. This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin. Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within a few weeks of the PACD. This period can be extended by the Sponsor. In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.

    Phase

    3

    Span

    268 weeks

    Sponsor

    AstraZeneca

    Antalya

    Recruiting

  • The Effect of Education Given to Type 2 Diabetics on Diabetes Self-management, Health Fatalism and Metabolic Parameters

    This study aims to determine the effect of education given with motivational interviewing technique structured according to the health belief model on diabetes self-management, health fatalism and metabolic parameters in individuals with type 2 diabetes. The research will be conducted in a pre-test and post-test randomized controlled experimental design.The population of the study will consist of individuals with type 2 diabetes who are registered in a health institution between February 2025 and May 2025 and who meet the research criteria. The sample determined by power analysis will consist of a total of 66 patients, 33 in the experimental group and 33 in the control group. Patient Introduction Form, Type 2 DM Self-Management Scale (SMS) and Health Fatalism Scale will be used to collect data from the experimental and control groups for pre-test and post-test. Weight, height, waist circumference and body mass index of the individuals will be measured by the researcher and HbA1c values of the last one month will be recorded. The experimental group will be given diabetes education with motivational interviewing technique structured according to the health belief model in line with the literature.Brochures and powerpoint presentations will be prepared as training materials. Trainings will be held in the training room on the days and times determined with the patients in 8 sessions lasting 30-40 minutes. At the end of the training, an SMS message will be sent once a week for four weeks. At the end of each visit, the next visit will be scheduled. Trainings will be conducted face-to-face by the researcher. The control group will not receive any training. After the completion of the trainings, a post-test will be administered to both the experimental and control groups. In the evaluation of the data; numbers, percentages, standard deviation, mean, minimum and maximum values, Chi-square, Fisher-Freeman-Halton Exact Test, Paired Samples t-test and Independent Samples t-test will be used.

    Phase

    N/A

    Span

    18 weeks

    Sponsor

    Ataturk University

    Antalya

    Recruiting

    Healthy Volunteers

  • Does the Phoenix Pediatric Sepsis Prognosis Prediction Scale Work

    Pediatric sepsis is a serious clinical syndrome leading to organ dysfunction develops in children due to infection. Various scoring systems are used to diagnose, treat and asses for pediatric sepsis. The most common of these Pediatric Risk of Mortality Score III (PRISM III) and Pediatric Logistic Organ Dysfunction (PELOD) scores. PRISM III is a set of 17 physiologic scores measured within the first 24 hours of ICU admission that predicts mortality risk based on the variable. In addition PELOD measures morbidity by assessing dysfunction in six organ systems. These scores are important in the management of pediatric sepsis. tools, but they also have some limitations. For example, the PRISM III score, does not take into the reason for the admission, underlying disease, infectious agent and response to treatment of the patient. PELOD score does not reflect the duration and severity of organ dysfunction. Therefore, new studies and improvements in the definition of pediatric sepsis and scores are in progress. Pediatric SOFA (pSOFA) score is another option for definition and to approach the pediatric sepsis. It is used to assess the severity of sepsis and organ function in children. These criteria include respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. For each system, specific parameters are considered and scored. These scores are summed to calculate the SOFA score and the risk of organ failure is estimated. The Pediatric Functional Status Scale (FSS) is a rapid, objective and reliable tool used to assess the functional status of children during hospitalization. FSS, mental status, sensory function, communication, motor function, nutrition and respiratory status and each area is given a score between 1 (normal) and 5 (very severe dysfunction). Total scores range from 6 to 30. In recent years, a new set of criteria called the Phoenix criteria a definition of pediatric sepsis has been proposed. Phoenix criterias which includes both systemic inflammatory response syndrome (SIRS) and organ dysfunction criterias aims more accurate and early recognition of pediatric sepsis. Whether the Phoenix criteria are compatible with PRISM III and PELOD scores has not yet been investigated. The aim of this study to understand the compatibility of Phoenix Score, International 2005 SIRS criterias and PRISM III, PELOD scoring systems. Defining pediatric sepsis in our research, epidemiology, scoring systems and prognosis. In addition, we will evaluate the advantages and disadvantages of the Phoenix criteria and assess the compatibility in pediatric sepsis scoring systems. The subject of our research is the use of the Phoenix criteria for pediatric sepsis. The aim of this study was to evaluate whether the 2005 SIRS - Sepsis diagnostic and grading criteria, pSOFA, PRISM III and PELOD scores are compatible and to compare their prognostic predictive power. The study is a 1-year prospective observational study. Patients will not undergo any interventional procedure or blood tests due to this study. No intervention will be made in the treatment protocol. In this study, Akdeniz University medical patients admitted to the Faculty of Pediatric Emergency Department with clinical sepsis suspicion will be included in the study. In 2024 it was aimed to evaluate whether the Phoenix criteria, which are recommended to be used to evaluate the prognosis of sepsis in pediatric patients, are compatible with the 2005 SIRS sepsis diagnosis and grading criteria, pSOFA, PRISM III and PELOD scores, which were widely used for this purpose in previous years and described in detail in the introduction section, and to compare their predictive power in terms of morbidity and mortality. Patient/Volunteer/Participant definition and number: The patient group consisted of patients admitted to the Pediatric Emergency Department of Akdeniz University Faculty of Medicine who were clinically suspected of sepsis or admitted to the general pediatric service or pediatric intensive care unit with suspected sepsis. The study is a one-year prospective observational study. The number of patients will be determined by the number of patients admitted during this period and the group of patients with suspected sepsis.

    Phase

    N/A

    Span

    67 weeks

    Sponsor

    Oguz Dursun

    Antalya

    Recruiting

  • Time for a Diagnostic Paradigm Shift From STEMI/NSTEMI to OMI/NOMI

    I. BACKGROUND AND SIGNIFICANCE The patients with acute coronary occlusion (ACO) or potentially imminent occlusion, with insufficient collateral circulation, have myocardium that is at risk of infarction unless they undergo immediate reperfusion via thrombolytics or percutaneous coronary intervention (PCI). One of the most important tasks in emergency cardiology is to immediately identify acute coronary occlusion (ACO) myocardial infarction (OMI) among all patients who present with symptoms compatible with acute myocardial infarction (MI), and distinguish them from those without MI, and from those with MI that does not have ongoing myocyte loss (Non-OMI, or NOMI) who can be managed with medical therapy and for whom potentially harmful invasive interventions can be deferred. The electrocardiogram (ECG) plays a central role in this process. The presence or absence of ST-segment elevation (STE) is principally used to define patients who need emergent coronary revascularization, since subgroup analyses of the Fibrinolytic Therapy Trialists' (FTT) meta-analysis indicated that patients with STE on ECG gain a slightly better survival benefit from emergent reperfusion. After fine-tuning of STE cutoffs used in this analysis, universally agreed STEMI criteria became the current guideline-supported ECG paradigm. It is not clear why a disease of a known pathophysiology (ACO) was named with an inaccurate surrogate ECG sign (Q-wave MI/non-Q-wave MI or STEMI/non-STEMI) instead of the pathologic substrate itself (ACO-MI/non-ACO-MI or OMI for short), but this fundamental mistake created important implications for our current practice. As briefly outlined above, ACO can be reliably recognized with the help of many other ECG findings, such as minor STE not fulfilling STEMI criteria, STE disproportionate to preceding QRS, unusual patterns with contiguous leads showing opposite ST deviations and some patterns not showing STE at all. Recently, the DIagnostic accuracy oF electrocardiogram for acute coronary OCClUsion resuLTing in myocardial infarction (DIFOCCULT) study, compared OMI/non-OMI approach with STEMI/non-STEMI paradigm. This is the largest study specifically designed to question the STEMI/non-STEMI paradigm, in which a set of predefined ECG findings in addition to STEMI criteria were used, and the final outcome was a composite ACO endpoint. In accordance with the previous observations, over one-fourth of the patients initially classified as having non-STEMI were re-classified by the ECG reviewers, blinded to all outcome data, as having OMI. This subgroup had a higher frequency of ACO, myocardial damage, and both in-hospital and long-term mortality compared to the non-OMI group. The OMI/non-OMI approach to the ECG had a superior diagnostic accuracy compared to the STE/non-STEMI approach in the prediction of both ACO and long-term mortality. II. THE HYPOTHESIS Our hypothesis is that the new OMI/NOMI approach will be superior to the established STEMI/NSTEMI paradigm in early detection of ACO, limiting infarct size, reducing rehospitalizations and most important of all, reducing mortality. III. METHODS 1. Application for Institutional Review Board (IRB)/Ethics board approval IRB/Ethics board approval is obtained from Marmara University Ethical Board. Each principal investigator at each individual study site will be required to obtain IRB/Ethics board approval from his/her own institution. 2. Study population The adult patients (age >18 years) who are admitted to the emergency department with a clinical picture compatible with acute coronary syndrome will be screened for enrollment into the study. patients with an ECG or clinical (see below) diagnosis of acute myocardial infarction will be enrolled into the study. An ECG will be acquired as soon as possible in all screened patients and serial ECGs will be taken if the first one is not diagnostic. The ECGs will be scanned and digitized via an artificial intelligence (AI)-powered mobile phone application. If the patient gets a STEMI or OMI diagnosis by the ECG or clinical gestalt (refractory pain, hemodynamic instability, arrhythmia, cardiac arrest) they will be included in the study even if the later troponin results turn negative. If the ECG is not diagnostic for OMI or STEMI, a myocardial infarction diagnosis with a positive troponin will be necessary for the inclusion in the study. According to 4th universal definition of MI, the term acute MI will be used when there is acute myocardial injury (detection of a rise and/or fall of cTn values with at least one value above the 99th percentile upper range limit) with at least one of the following clinical indicators of acute myocardial ischemia: - Symptoms of myocardial ischemia; - New ischemic ECG changes; - Development of pathological Q waves; - Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology; - Identification of a coronary thrombus by angiography or autopsy; - Post-mortem demonstration of acute atherothrombosis in the artery supplying the infarcted myocardium. All non-procedure related (excluding type 4a and 5 MIs), including type 1 (MI caused by atherothrombotic coronary artery disease which is usually precipitated by atherosclerotic plaque disruption (rupture or erosion)), type 2 (evidence of an imbalance between myocardial oxygen supply and demand unrelated to acute atherothrombosis), type 3 (cardiac death in patients with symptoms suggestive of myocardial ischemia and presumed new ischemic ECG changes before cTn values become available or abnormal) and type 4b and c (stent/scaffold thrombosis ore restenosis associated with percutaneous coronary intervention) will be included in the study. Patients with myocardial injury (either acute, as in acute heart failure or myocarditis, or chronic, as in chronic kidney disease or stable increased troponin levels with structural heart disease) without ischemia (abovementioned following clinical indicators of acute myocardial ischemia) will be excluded from the study. Randomization The patients will be randomized to the current STEMI/NSTEMI versus OMI/NOMI approaches using a cluster randomized trial design. Although the STEMI/NSTEMI approach is the current norm (a diagnosis of STEMI requires emergent catheterization, whereas the patients with NSTEMI are stabilized first and then electively undergo catheterization unless there are high-risk features), it would be unethical for a ECG reviewer, who is trained in recognizing the signs of ACO not fulfilling the current STEMI criteria, to suspend emergent reperfusion therapy after an OMI diagnosis has been made. Therefore, the ECG interpreters who are trained in OMI diagnosis cannot be randomized to STEMI/NSTEMI versus OMI/NOMI approaches. Hence, the groups will be randomized in the following fashion: In each center, a STEMI/NSTEMI and an OMI/NOMI intervention group will be formed. After these two groups are formed, the patients will be block-randomized into STEMI/NSTEMI and will be screened for enrollment into the study. patients with an ECG or clinical&#xd; (see below) diagnosis of acute myocardial infarction will be enrolled into the&#xd; study.&#xd; &#xd; An ECG will be acquired as soon as possible in all screened patients and serial ECGs&#xd; will be taken if the first one is not diagnostic. The ECGs will be scanned and&#xd; digitized via an artificial intelligence (AI)-powered mobile phone application. If&#xd; the patient gets a STEMI or OMI diagnosis by the ECG or clinical gestalt (refractory&#xd; pain, hemodynamic instability, arrhythmia, cardiac arrest) they will be included in&#xd; the study even if the later troponin results turn negative. If the ECG is not&#xd; diagnostic for OMI or STEMI, a myocardial infarction diagnosis with a positive&#xd; troponin will be necessary for the inclusion in the study. According to 4th&#xd; universal definition of MI, the term acute MI will be used when there is acute&#xd; myocardial injury (detection of a rise and/or fall of cTn values with at least one&#xd; value above the 99th percentile upper range limit) with at least one of the&#xd; following clinical indicators of acute myocardial ischemia:&#xd; &#xd; - Symptoms of myocardial ischemia;&#xd; &#xd; - New ischemic ECG changes;&#xd; &#xd; - Development of pathological Q waves;&#xd; &#xd; - Imaging evidence of new loss of viable myocardium or new regional wall motion&#xd; abnormality in a pattern consistent with an ischemic etiology;&#xd; &#xd; - Identification of a coronary thrombus by angiography or autopsy;&#xd; &#xd; - Post-mortem demonstration of acute atherothrombosis in the artery supplying the&#xd; infarcted myocardium.&#xd; &#xd; All non-procedure related (excluding type 4a and 5 MIs), including type 1 (MI caused&#xd; by atherothrombotic coronary artery disease which is usually precipitated by&#xd; atherosclerotic plaque disruption (rupture or erosion)), type 2 (evidence of an&#xd; imbalance between myocardial oxygen supply and demand unrelated to acute&#xd; atherothrombosis), type 3 (cardiac death in patients with symptoms suggestive of&#xd; myocardial ischemia and presumed new ischemic ECG changes before cTn values become&#xd; available or abnormal) and type 4b and c (stent/scaffold thrombosis ore restenosis&#xd; associated with percutaneous coronary intervention) will be included in the study.&#xd; Patients with myocardial injury (either acute, as in acute heart failure or&#xd; myocarditis, or chronic, as in chronic kidney disease or stable increased troponin&#xd; levels with structural heart disease) without ischemia (abovementioned following&#xd; clinical indicators of acute myocardial ischemia) will be excluded from the study.&#xd; &#xd; Randomization The patients will be randomized to the current STEMI/NSTEMI versus&#xd; OMI/NOMI approaches using a cluster randomized trial design. Although the&#xd; STEMI/NSTEMI approach is the current norm (a diagnosis of STEMI requires emergent&#xd; catheterization, whereas the patients with NSTEMI are stabilized first and then&#xd; electively undergo catheterization unless there are high-risk features), it would be&#xd; unethical for a ECG reviewer, who is trained in recognizing the signs of ACO not&#xd; fulfilling the current STEMI criteria, to suspend emergent reperfusion therapy after&#xd; an OMI diagnosis has been made. Therefore, the ECG interpreters who are trained in&#xd; OMI diagnosis cannot be randomized to STEMI/NSTEMI versus OMI/NOMI approaches.&#xd; Hence, the groups will be randomized in the following fashion: In each center, a&#xd; STEMI/NSTEMI and an OMI/NOMI intervention group will be formed. After these two&#xd; groups are formed, the patients will be block-randomized into STEMI/NSTEMI and&#xd; OMI/NOMI cohorts according to the team on-duty, i.e., the approach that center will follow on a certain day will be defined by the team on duty. The interventional cardiologists in both groups will be ensured to have a similar experience level (in terms of years of training, and angiography and primary PCI counts in the past year). All possible first responders in the network of a study center (who contact the patient first, according to the center this can be either a referring physician, an emergency physician or a cardiologist) will be provided with an AI-powered application for ECG diagnosis. These responders will receive diagnostic prompts from the application according to the center's on-duty team. If an OMI team member is on duty, the ECG interpretation will be OMI or not-OMI. If a STEMI team member is on-duty, the ECG interpretation will be disabled and will read "follow standard care". The first responder will thus elect to go for catheterization based on this approach and, whether that is by OMI or STEMI paradigm, the patient will be enrolled accordingly and the reason for proceeding to the catheterization laboratory will be written on the study form (or electronic sheet on the dedicated website). In the STEMI/NSTEMI arm, the contributors will blindly continue their usual practice, the ECG interpretation and decision to activate the catheterization laboratory will be done as usual. The STEMI/NSTEMI group will use the following criteria for the diagnosis of STEMI: (1) New ST-segment elevation at the J-point in two contiguous leads with the cut-point: ≥ 1 mm in all leads other than leads V2-V3 where the following cut-points apply: ≥2 mm in men ≥40 years; ≥2.5 mm in men <40 years, or ≥1.5 mm in women regardless of age, and (2) a peak troponin level above 99th percentile with a characteristic rapid rise and fall (retrospectively) and (3) a clinical picture compatible with acute coronary syndrome. If the decision to proceed to the cath lab was done only with the first criterion, the participant will remain in the study, even if the second criterion is not met. The patients meeting only criteria (2) and (3) will be classified as NSTEMI. On OMI/NOMI days, physicians are encouraged to actively search for ACO, regardless of whether STEMI criteria are present on the initial ECG. A diagnosis of OMI can be based on clinical gestalt, ECG findings, and adjunct modalities. Clinical gestalt includes hallmark presentations such as almost pathognomonic chest pain, and ischemic arrhythmias, hemodynamic instability, or cardiac arrest following typical symptoms. ECG diagnosis, whether interpreted by physicians or aided by an AI-powered smartphone application, incorporates static or serial changes for ACO using the DIFOCCULT-1 study algorithm. On OMI/NOMI days, the smartphone application is activated and available to all first responders associated with this center. This application assists diagnosis, but the final decision is left to the interventionalist on duty. Adjunct modalities include bedside echocardiography demonstrating new or presumed new wall motion abnormalities in patients with ongoing or recurrent chest pain, and significantly elevated initial troponin levels. For high-sensitive cardiac troponin (hs-cTn) T, it has been shown that a level exceeding 1000 ng.mL-1 is highly specific for major epicardial coronary artery occlusion. Similarly, a hs-cTn I >200 times the upper limit of normal (e.g., Architect, Abbott Diagnostics, Illinois, USA: 5000 ng/L; ADVIA Centaur, Siemens Healthcare, Tarrytown, USA: 5000 ng/L; Access, Beckman Coulter, Brea, USA: 2400 ng/L) is defined as a marker for OMI in patients with ongoing or fluctuating chest pain. In patients diagnosed with OMI, immediate catheterization laboratory activation with the intent to perform PCI is pursued. In NOMI patients, initial medical stabilization is prioritized, followed by elective catheterization per the NSTEMI pathway unless high-risk features are identified. STEMI and OMI patients (will be taken as STEMI equivalents for therapeutic purposes) will be managed according to the current STEMI guidelines, whereas NSTEMI and NOMI patients are managed according to the current NSTEMI guidelines. A separate diagnostic group with 'probable OMI' and 'high-risk STEMI' is also allowed for patients who do not fulfil STEMI/OMI criteria but need urgent catheterization for other high-risk features or high clinical suspicion for having an ACO. These patients will also be managed according to the current guidelines. However, patients will be excluded from analysis if their early catheterization is based solely on social or logistical considerations, and not based on the medical need. For example, a patient would be excluded if he/she is brought to the cath lab early based on the immediate availability of cath lab or because the patient is already scheduled for elective coronary angiography. The patients who have alternative diagnoses (myocarditis, pericarditis, pulmonary embolism etc.) but were not included due to a clinical or ECG diagnosis of STEMI/NSTEMI or OMI/NOMI will be excluded from the study. Similarly, the patients without a characteristic troponin kinetics who were not included due to a clinical or ECG diagnosis of STEMI/NSTEMI or OMI/NOMI will be excluded from the study. Endpoints The primary composite endpoint is all-cause mortality and all-cause re-hospitalization during follow-up across the entire cohort. The study places equal emphasis on a predefined evaluation of the OMI (+) NSTEMI. The secondary comparisons will be done for the presence of ACO on angiogram, false positive catheterization laboratory activation rate, the infarct size as defined by 24-72 hour peak troponin, wall motion score index (WMSI), left ventricular ejection fraction (LVEF), in-hospital CPR, intubation and mortality. These will be analyzed both with intention to treat and per protocol approaches. To define this subgroup in the OMI/NOMI arm, all ECGs diagnosed as OMI during the study will be randomly assigned to researchers in the STEMI/NSTEMI arm after study completion. The researchers will then assess whether the ECG is compatible with STEMI or NSTEMI. Patients diagnosed as NSTEMI within the OMI group will be classified as the OMI (+) NSTEMI subgroup in the OMI/NOMI arm. In the STEMI/NSTEMI arm, patients diagnosed with NSTEMI will have their ECGs scanned and interpreted by the AI-powered application. If the ECG is interpreted as OMI, these patients will be included in the OMI (+) NSTEMI subgroup within the STEMI/NSTEMI arm. The OMI diagnosis also includes clinical variables, such as clinical gestalt and very high first troponin levels. However, clinical gestalt cannot be acted upon retrospectively (e.g., bedside echocardiography or serial ECGs). Nevertheless, if a patient is recorded with ongoing chest pain and a very high first troponin level (based on center-specific and troponin kit-specific values), this will be included in the OMI (+) NSTEMI subgroup in the STEMI/NSTEMI arm, even if the ECG is not interpreted as OMI by the AI-powered application. The primary source of outcome data will be the Turkish national electronic database (e-nabız), which provides comprehensive, real-time updates on all deaths and hospitalizations nationwide. To ensure the completeness and accuracy of data, direct phone contact with participants or their families will be conducted as a secondary measure. All collected outcomes will be reviewed by an independent outcome adjudication board blinded to the study arms. Estimated number of subjects to be submitted: For the overall cohort, we estimated that enrolling 3,185 participants would provide 95% statistical power to detect a hazard ratio (HR) of 0.87, corresponding to a 13% relative risk reduction in the combined primary endpoint for the OMI/NOMI approach compared to the STEMI/NSTEMI approach. To account for the hierarchical nature of our study design and the structured nature of PCI-based STEMI/NSTEMI treatment pathways, we selected an intra-cluster correlation coefficient of 0.015 and an average cluster size of 50 patients per interventionalist team. Applying a design effect correction of 1.74, this adjustment increased our required sample size from 3,185 to 5,526 participants. To maintain feasibility and account for potential dropouts, the final target enrollment was rounded to 6,000 patients. For the OMI (+) NSTEMI subgroup analysis, this sample size was also sufficient. This sample size is also expected to provide sufficient power to detect at least a 10% relative improvement in infarct size, left ventricular ejection fraction, and wall-motion score index among STEMI (-) OMI (+) patients undergoing early revascularization in the OMI arm compared to those receiving standard-timing revascularization in the STEMI/NSTEMI arm, assuming a 30% OMI prevalence in the NSTEMI cohort and for a ROC comparison. 3. Participating centers Listed elsewhere. 4. Data Collection From September 1, 2024, AI-powered ECG App will be distributed to the referring hospitals by the participating centers. The study will start at all participating centers on October 1, 2024. A dedicated website (difoccult.org) will be used for data entry and storage. Study data is collected and managed using REDCap (Research Electronic Data Capture) tool hosted at a dedicated server. REDCap is a secure, web-based software platform designed to support data capture for research studies, providing (1) an intuitive interface for validated data capture; (2) audit trails for tracking data manipulation and export procedures; (3) automated export procedures for seamless data downloads to common statistical packages; and (4) procedures for data integration and interoperability with external sources. A data monitoring board ensures the completeness, integrity, and accuracy of the entries, providing feedback to the data entry team and requesting explanations or modifications as needed. Baseline variables Collected baseline variables and their definitions are listed in the REDCap printout in the supplemental file. Electrocardiogram ECGs will be acquired using standard conventions. If the first ECG is non-diagnostic, serial ECGs will be acquired every 15 minutes for an hour and the first diagnostic ECG will be used in the analyses. If all of them are non-diagnostic the physician may still use additional tools such as the clinical picture, bedside echocardiogram, troponin results to diagnose 'high-risk NSTEMI' or 'possible OMI'. All pre-intervention ECGs and at least one pre-discharge ECG will be uploaded to a central cloud database to be retrospectively reviewed by core lab investigators. The absence of a technically adequate pre-cath ECG will be a reason for the exclusion of the participant. If ECG diagnosis is not compatible with the inclusion criteria for the assigned group, this will be noted and the patient will be excluded from the per-protocol analyses. Following coding will be used for ECGs: Type 1 EGGs: New ST-segment elevation at the J-point in two contiguous leads with the cut-point: ≥ 1 mm in all leads other than leads V2-V3 where the following cut-points apply: ≥ 2mm in men ≥ 40 years; ≥ 2.5 mm in men < 40 years, or ≥ 1.5 mm in women regardless of age. Type 1a: The amplitude, morphology, extent of STE and the presence of additional findings (hyperacute T waves, Q-waves, terminal QRS distortion) make ECG highly obvious for MI presumably due to acute, thrombotic occlusion. These ECGs will be included in both STEMI and OMI definitions. Type 1b: There is ST-segment elevation that meets criteria for STEMI, but it is uncertain whether it is due to MI or to another condition, such as benign variant STE, left ventricular hypertrophy, left bundle branch block, prior MI, pericarditis, etc. These ECGs will be included in the STEMI definition but not in the OMI definition, unless there are additional findings suspicious for acute coronary occlusion as follows: Differential diagnosis for benign variant STE: Type 1b, if fulfills STEMI criteria. But re-classified as Type 2b, if the Aslanger/Smith formula is positive. Aslanger's formula: (R-wave amplitude in lead V4 + QRS amplitude in V2) - (QT interval in millimeters + STE60 in V3) <12 (Aslanger E Am J Cardiol, 2018). Differential diagnosis for left ventricular hypertrophy: Type 1b unless ST segment to R-S-wave magnitude is equal or greater than 15% (then indicates OMI, Type 2b) (Armstrong EJ et al. Am J Cardiol, 2012, Aslanger et al. Arch Turk Soc Cardiol, 2021). Differential diagnosis for isolated left bundle branch block: Will be coded as Type 1b, unless one of the modified Sgarbossa criteria is positive (then indicates OMI, Type 2b): ≥ 1 lead with ≥1 mm of concordant ST elevation, ≥ 1 lead of V1-V3 with ≥ 1 mm of concordant ST depression, ≥ 1 lead anywhere with ≥ 1 mm STE and proportionally excessive discordant STE, as defined by ≥ 25% of the depth of the preceding S-wave (Smith SW et al. Ann Emerg Med 2012). Differential diagnosis for prior MI: Type 1b, unless Smith's rule is positive (then indicates OMI, Type 2b): Smith's rule: If any 1 lead between V1-V4 has a T-wave amplitude to QRS amplitude ratio greater than or equal to 0.36 (Klein LR et al. Am J Emerg Med 2015). Differential diagnosis for pericarditis: Type 1b, unless there is ST-depression in aVL (then indicates OMI, Type 2b) (Bischof JE et al. Am J Emerg Med. 2016). Type 1c: There is ST-segment elevation that meets criteria for STEMI, but there is also T-wave inversion and pathologic Q waves indicative of subacute MI. These ECGs will be excluded from per-protocol analyses, since these patients have ACO on angiogram and higher long-term mortality but gain little, if not any, benefit from reperfusion with both approaches. Patients with preserved QRS complexes (Wellens' pattern) will be included in type 2c ECGs. Type 2 EGGs: ECG that meets acute myocardial ischemia criteria recommended by fourth universal definition of MI. Type 2a: The ECG has "primary'', i.e. cannot be completely explained as secondary to a depolarization disorder, ST-segment depression or T-wave inversion that is nondiagnostic of STEMI but is diagnostic of myocardial ischemia. Type 2b: Does not meet recommended criteria for STEMI, but highly suggestive for ACO, despite being subtle and difficult. Possible findings are minor STE with or without minor reciprocal ST-depression not fulfilling STEMI criteria, hyperacute T-waves or DeWinter's pattern, subtle anterior STE hard to differentiate from benign variant STE and nonconsecutive STE. These ECGs will be included in the OMI definition but not in the STEMI definition. The detailed algorithm defined in the DIFOCCULT trial (Aslanger et al. In J Cardiol Heart Vasc, 2020; Aslanger et al. J Electrocardiol, 2021; Aslanger et al. Arch Turk Soc Cardiol, 2021) will be used for recognizing these ECGs. Type 2c: Patients with preserved QRS complexes (Wellens' pattern), with or without some STE, but with significant T wave negativity will be included in type 2c ECGs. These ECGs will be excluded from per-protocol analyses, since these patients may not gain benefit from emergent reperfusion in both approaches. Type 3 ECGs: Nonspecific ECG that is abnormal but nondiagnostic of any kind of acute coronary syndrome. Minor abnormalities including left ventricular hypertrophy without ST-T changes, arrhythmias, impulse generation and conduction diseases etc. Type 4 ECGs: Completely normal ECG. AI-Powered ECG Application In OMI/NOMI arm ECGs can be digitized and interpreted by AI-powered ECG application prospectively. In STEMI/NSTEMI arm, interpretation will be done retrospectively. The application's functionality varied based on the study arm determined by the team on duty. On OMI/NOMI days, the AI application is fully activated and accessible to all first responders associated with that center. When a user captures a photo of an ECG, the application digitalizes the image, interprets the data, and displays one of two messages: "OMI" or "Not-OMI." First responders were instructed to promptly inform the interventionalist on duty for potential catheterization laboratory activation if result shows "OMI". On STEMI/NSTEMI days, the AI-supported application is deactivated for that center. If a first responder attempts to capture a photo of an ECG, a warning message is displayed: "We are now following the standard STEMI/NSTEMI approach. Please continue your usual practice." A commercial version of the same smartphone application by the same company is also available on the market. During the study, if a network address is detected accessing both the commercial and study-specific applications, the commercial version is deactivated by the company, and a notification mail is sent explaining that the commercial smartphone application will not be available to users in Türkiye for the duration of the study. Additionally, all ECGs stored in the study database will be cross-referenced with the commercial smartphone application's ECG history. If any matches are identified, the corresponding patient will be excluded from the study. After the study completion, ECGs in both study arms will be reviewed and coded as defined above for intention-to-treat and per-protocol analyses. This will be done by two separate ECG interpreter. Should there be any discrepancy between these interpreters, a third interpreter (from data monitoring board) will be consulted. Type 1a, 1b and 1c ECGs will be deemed as compatible with STEMI. Type 1a, 2b and 2c ECGs will be deemed compatible with OMI diagnosis. Troponins The troponin levels will be measured at admission, hourly if needed for the diagnosis, every 6 hours until it peaks after an MI diagnosis is made, and then daily. The 24-72 hour peak troponin level (usually 48h) will be used as a surrogate for infarct size. Angiograms Coronary angiography will be undertaken according to the standard conventions. Each angiogram will be reviewed by two interventionalist. Should there be any discrepancy between these interpreters, a third interpreter (from data monitoring board) will be consulted. Following points will be noted for the presence of an ACO: (1) the Thrombolysis in Myocardial Infarction Study (TIMI) flow level in the infarct-related vessel. The presence of well-developed collaterals to the distal vessel, appearance of the total occlusion, easiness of guidewire crossing will also be assessed to determine if the total occlusion is acute in nature. If necessary, the primary operator will also be contacted. (2) The presence of an acute lesion with definitive culprit features, which was defined based on several angiographic properties including critical stenosis, irregular lesion borders, presence of angiographic thrombus or staining. ACO Adjudication Because the infarct-related artery may spontaneously open by the time of the angiogram or total occlusion may be chronic in nature, a composite ACO using following criteria is defined: 1. An acute culprit lesion with TIMI 0-2 flow PLUS a peak troponin level equal to or greater 5 than five times the ULN PLUS at least 20% rise within the first 24 hours 2. A highly elevated peak (for troponin T>1000 ng/mL and for troponin I 200 times of the average of ULN (known to be highly correlated with ACO)) without an obvious alternative diagnosis or with supporting evidence (ECG evolution, culprit-looking lesion on angiogram in a coronary territory compatible with ECG/echocardiographic area at concern) 3. cardiac arrest before any troponin rise has been documented with supporting clinical evidence of possible ACO. Follow-up The last participant in the study will be followed up to one year. The survival status and re-hospitalization will be checked from the national database and a phone call, if required. Statistical Analysis Baseline characteristics will be summarized using standard descriptive statistics. Comparisons of relevant parameters between groups will be performed by chi-square, Fisher's exact test, Mann-Whitney U, and student t-test, as appropriate. Patients with missing values will be excluded pairwise from analyses. A Cohen's κ test will be used for determination of the intra- and inter-observer agreement for ECG classifications and ACO adjudication. Kaplan-Meier analysis will be performed to determine the cumulative long-term mortality rates in different ECG subgroups. The mortality across groups will be compared using a log-rank test. A Cox-regression model will be used to perform a survival analysis according to basal GRACE risk score, intervention timing and treatment status. Baseline characteristics with a P value of 0.05 or less in the univariate analysis will be included and a step-down procedure will be applied for selection of final covariates. To address potential variability in outcomes due to interventionist or center-related factors, we will incorporate a random effects (frailty) term into the Cox model. The calibration cohort (the patients with type 1a ECGs and treat with the same manner in both arms) will be used to estimate variability attributable to interventionist practices. The random effect variance (σ2) calculated from this cohort will inform the frailty term in the full Cox model, ensuring that differences in outcomes due to interventionist-related variability are appropriately adjusted. The final model will include patient-level covariates, random effects for interventionists or centers, and calibration adjustments based on the calibration cohort. The sensitivity, specificity and diagnostic accuracy of STEMI/NSTEMI or OMI/NOMI ECG approaches will be calculated using receiver operating characteristics analysis. As these parameters are highly dependent on the pre-test probability of the disease and pre-test probability of ACO and long-term mortality are closely associated with the presentation type, the investigators will also repeat these analyses after weighing cases for the total number of hospital admissions in the study period. Statistical analyses will be performed with SPSS (version 24.0; SPSS Inc., Chicago, IL) and MedCalc Software (version 18.2.1 [Evaluation version]; MedCalc Software, Ostend, Belgium). 5. Safety monitoring and reporting Study REDCap forms necessitate in-hospital adverse events to be actively collected to monitor and report any in-hospital adverse events. An independent Data Safety Monitoring Board (DSMB) has been established to oversee the safety and progress of the trial. The DSMB convened via teleconference during the pretrial period, upon enrollment of 20% of the participant sample size, and will continue to meet after each subsequent 20% enrollment milestone. The primary objective of the DSMB is to monitor enrollment milestones and the safety of the interventions. A four-point combined safety endpoint will be closely monitored: (1) myocardial infarction size by 48.hour troponin, ejection fraction and wall motion score index; (2) integrity of coronary intervention by in-hospital stent thrombosis; (3) integrity of in-hospital care by in-hospital intubation, in-hospital cardiopulmonary resuscitation and in-hospital mortality and (4) long-term therapy by discharge treatment. If a statistically significant increase in this four-point combined safety endpoint is observed in either of the study arms after the enrollment of any 20% of the participant sample size, the DSMB will make a recommendation regarding the revision, rearrangement or potential exclusion of the study participants or the study center. 6. Study integrity The study is an investigator-initiated trial conducted under the auspices of the Turkish Society of Cardiology. The Turkish Society of Cardiology supports the investigator team in developing the trial design and organizing the participating centers. The steering committee oversees the processes of recruitment, consent and assent, follow-up, and ensures the validity and integrity of data acquisition. The trial has been approved by the Ethical Board of Marmara University (09.2021.523), any change in protocol or centers will be addressed by this board. The study will be conducted in accordance with Good Clinical Practice guidelines.

    Phase

    N/A

    Span

    105 weeks

    Sponsor

    Başakşehir Çam & Sakura City Hospital

    Antalya

    Recruiting

  • Effect of Motivational Interviewing on Sleep Hygiene, Sleep Quality and Quality of Life

    After the pre-tests are applied to the patients in the intervention group, face-to-face sleep hygiene training will be given, and then 4 sessions of motivational interviews will be held within 6 weeks. The sessions will be conducted online with each patient individually. The post-test will be applied 10 weeks after the pre-test.

    Phase

    N/A

    Span

    29 weeks

    Sponsor

    Akdeniz University

    Antalya

    Recruiting

  • Evaluation of the Levels of Calcitonin Gene-related Peptide and Substance P

    Adult patients (18 years of age and older) with suspected CSF drainage system-related meningitis who are followed up in the Intensive Care Unit will be included in the study. Blood and CSF samples taken during routine clinical practice (before the development of meningitis symptoms, just before the first dose of antibiotherapy on the first day of meningitis symptoms, after the last dose of antibiotherapy on the 3rd day of antibiotherapy), CSF smear, CSF culture and CSF direct examination, CSF biochemistry parameters will be studied, and the materials will be taken into tubes containing aprotinin (proteinase inhibitor) to study CGRP and substance P levels in blood and CSF materials to be destroyed. CGRP and substance P levels will be analysed by ELISA method. Among the clinical parameters, the patient's state of consciousness (Glasgow coma scale), fever response, vasoactive drug requirement, organ failure, sepsis and septic shock status, SOFA and APACHE II scores will be recorded. Laboratory parameters available in routine clinical practice (haemogram, biochemical tests, microbiological growths, infection parameters), radiographic examination findings (computed brain tomography, brain magnetic resonance imaging), intensive care unit length of stay and intensive care unit outcomes (survival/mortality) will also be recorded for use in the analysis.

    Phase

    N/A

    Span

    79 weeks

    Sponsor

    Melike Cengiz

    Antalya

    Recruiting

  • PVP-Guided Decongestive Therapy in HF 2

    I. BACKGROUND AND SIGNIFICANCE Precise assessment of volume status is essential in diagnosis and management of diuretic therapy in patients hospitalized for heart failure (HF). Unfortunately, no clear guidelines are present for in-hospital management of congestion. Consequently, nearly half of the patients hospitalized for congestive HF are discharged with persistent congestion. This contributes to high rates of readmission and mortality. Recently, it has been shown that a simple assessment of peripheral venous pressure (PVP) demonstrates a high correlation with central venous pressure (CVP), indicating that PVP may be useful in the standard bedside clinical assessment of volume status in HF patients to help guiding decongestive therapy. II. THE HYPOTHESIS The main hypothesis is as follows: A simple assessment of peripheral venous pressure (PVP) will better guide the diuretic need and long-term outcomes (all-cause mortality, all cause re-hospitalization, emergency department visits) compared to standard evaluation. III. METHODS 1. Application for Institutional Review Board (IRB)/Ethics board approval The study will be at participating centers. An IRB/Ethics board approval has been obtained from Marmara University, Pendik Training and Research Hospital local ethics board. 2. Study population Patients 18-99 years old who were admitted with a de novo or decompensated chronic HF and accept to participate in the study will be enrolled. Patients will be included regardless of ejection fraction or etiology of HF, but these will be noted as baseline variables. All patients or legal surrogate decision makers will be requested to provide a written informed consent prior to enrollment. Patients who withdraw their consent, those with upper extremity venous pathology, those with a baseline creatinine level equal to or above 3.5 mg/dL, those with severe stenotic valvular disease and hypertrophic cardiomyopathy will be excluded. 3. Data Collection The study will start at participating centers on July 1, 2024. Baseline variables Baseline variables will be entered to the electronic study form (RedCap). Procedures A peripheral intravenous (IV) access, using an 18 to 22-gauge IV line, will be placed preferably to an upper extremity vein before enrollment. This line will be used to draw blood samples first. After blood samples were collected the subjects will be randomized to standard or PVP guided therapy groups. Randomization will be done using a computer-generated random allocation list via RedCap randomization module. The details of demographic characteristics, symptoms, physical examination findings and drug list will be noted to a standard electronic study form (see appendix). A routine electrocardiogram and echocardiogram will be performed at the earliest convenience. After the blood samples were collected, line will be flushed carefully. PVP will be obtained by transducing a peripheral intravenous line after zeroing at the phlebostatic axis. The phlebostatic axis will be accepted as the midpoint between the anterior and posterior surfaces of the chest at the level of the fourth intercostal space meets with sternum, which is assumed to be correlated with the mid-level of the right atrium. The patient's arm will be placed parallel to the patient such that the position of the peripheral IV to be at the phlebostatic axis. Continuity of the peripheral IV line with the central venous system will be confirmed by demonstrating augmentation of the venous pressure waveform using manual or tourniquet circumferential occlusion of the extremity proximal to the catheter and modified Valsalva maneuver. If the pressure waveform failed to augment appropriately, data will not be collected, and the patient will be documented for study purposes as a technique failure. Daily fluid intake and output, weight, and biochemistry measurements, as required, will be done. The patients in whom the first and the predischarge PVP cannot be measured due to technical issues (unable to provide upper extremity IV access, unable to confirm augmentation or Valsalva test) will be excluded from the study. Also, the patients requiring in-hospital intubation, high-dose inotrope or vasopressor infusion (≥10 mcg.kg-1.min-1 dopamine, dobutamine or equivalent), intraaortic balloon support, dialysis or veno-venous ultrafiltration will be excluded from the study (but these patients will be included in the in-hospital analyses). In hospital diuretic treatment will be guided by ESC guidelines (see references). In the standard therapy arm, the treatment and the decision of discharge will be left to physicians' discretion. In the PVP-guided arm, a PVP < 9 mmHg will be targeted before discharge. Outcomes The primary outcome of the study is the composite endpoint of all-cause mortality, all-cause hospitalization and all-cause emergency department visits. The secondary outcomes will include cardiovascular mortality, HF-related hospitalization, HF-related emergency department visits. This information on these outcomes will be obtained from the national electronic database. The follow-up duration is planned to be limited to one year. Predefined secondary analyses There will be subanalyses from the same cohort, as defined below: - The correlation between predischarge PVP and long-term outcomes. A multivariable analysis will also be executed for predicting the primary end point. - The correlation between the change in PVP during hospital stay and long-term outcomes. A multivariable analysis will also be executed for predicting the primary end point. - The correlation between the change in PVP during hospital stay and worsening renal function, renal injury, need for dialysis or veno-venous ultrafiltration. - The comparison of the two arms in terms of worsening renal function, need for dialysis or veno-venous ultrafiltration. - The comparison of the two arms in terms of EVEREST congestion score. - The comparison of the two arms in terms of the days in hospital. - The comparison of the two arms in terms of the number of repeat hospitalizations. - Usual patterns of diuretic use Estimated number of subjects to be submitted: We estimated that the enrollment of 621 participants would provide the study with a statistical power of 95% to detect a relative risk reduction of 26% (hazard ratio [HR] = 0.74) for the composite primary outcome (PVP-guided group: 40%, standard approach: 50%), using a two-sided test at the 0.05 significance level. This calculation assumes a 10% censoring rate and a 1-year follow-up period. The weighted event rate (πe=45%) was used to estimate the required number of events. To account for potential loss to follow-up and ensure robust analysis, the sample size was increased to 650 participants, maintaining equal allocation between groups (1:1 randomization). Statistical Analysis Baseline characteristics will be summarized using standard descriptive statistics. Comparisons of relevant parameters between groups will be performed by chi-square, Fisher's exact test, Mann-Whitney U and student t-test, as appropriate. Kaplan-Meier analysis will be performed to determine the cumulative long-term mortality and composite outcome rates in subgroups. The mortality across groups will be compared using log-rank test. A Cox-regression model will be used to perform a survival analysis according to pre-discharge peripheral venous pressure and composite outcome. Baseline characteristics with a P value of 0.05 or less in the univariate analysis will be included and a step-down procedure will be applied for selection of final covariates. Statistical analyses will be performed with SPSS (version 24.0; SPSS Inc., Chicago, IL) and MedCalc Software (version 18.2.1 [Evaluation version]; MedCalc Software, Ostend, Belgium).

    Phase

    4

    Span

    105 weeks

    Sponsor

    Başakşehir Çam & Sakura City Hospital

    Antalya

    Recruiting

  • Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

    The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin. The study will be conducted at approximately 700 sites in approximately 40 countries globally.

    Phase

    3

    Span

    165 weeks

    Sponsor

    AstraZeneca

    Antalya

    Recruiting

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