Tbilissi, Georgia
PRemature Acute Myocardial Infarction Register of Serbia
Study Overview This national, multicenter study combines retrospective and prospective analyses to investigate AMI in patients aged ≤ 45 years in Serbia. The primary aim is to characterize the clinical, demographic, and angiographic profiles of these patients, identify specific risk factors, and evaluate treatment outcomes. The findings aim to inform prevention, early diagnosis, and treatment strategies for premature AMI. Objectives Primary Objectives: Determine the incidence and prevalence of AMI in this population. Analyze demographic characteristics and the prevalence of standard atherosclerotic risk factors (e.g., smoking, diabetes, hypertension, and socioeconomic status). Examine angiographic findings, including obstructive or non-obstructive coronary artery disease and other abnormalities. Secondary Objectives: Assess atherosclerotic plaque characteristics using OCT or IVUS imaging. Evaluate the prevalence of spontaneous coronary artery dissection (SCAD) and comorbid conditions like chronic kidney disease and autoimmune diseases. Investigate genetic predispositions (e.g., thrombophilia, familial hypercholesterolemia) and metabolic markers like homocysteine. Monitor treatment outcomes, including major adverse cardiovascular events (MACE) during hospitalization and at follow-ups. Design and Methodology The study adheres to the Universal Definition of Myocardial Infarction and includes detailed data collection: Demographics: age, gender, socioeconomic status, and rural vs. urban residency. Clinical Data: chest pain characteristics, ECG findings, and laboratory markers like lipids, homocysteine, and inflammatory markers. Imaging and Diagnostics: echocardiography, angiography, OCT/IVUS imaging, and cardiac MRI for MINOCA cases. Therapeutics: Analysis of treatment methods, including interventions, antiplatelet agents, and anticoagulants. Study Population Inclusion Criteria: Patients aged ≤ 45 years diagnosed with AMI who provide informed consent. Exclusion Criteria: Patients aged > 45 years. Sample Size and Data Analysis Approximately 200 participants will be enrolled annually, with a target of 1,000 participants over five years. Data will be analyzed using statistical methods to identify predictors of adverse outcomes and evaluate survival rates. Ethical Considerations This study complies with ethical standards and protects patient rights and data confidentiality. Participation is voluntary, and patients may withdraw at any time without affecting their care. Significance The study aims to close a critical knowledge gap regarding premature AMI, contributing to improved prevention and management strategies in young adults at the national level.
Phase
N/ASpan
105 weeksSponsor
Cardiology Society of SerbiaVrbas
Recruiting
Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation
Phase
3Span
127 weeksSponsor
Develco Pharma Schweiz AGVrbas
Recruiting