Phase
Condition
Chest Pain
Hyponatremia
Atherosclerosis
Treatment
Observational
Clinical Study ID
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects must meet all of the Inclusion Criteria to participate in the trial.
Age ≥18 years and <90 years
Scheduled for PCI or PROTECTED PCI in near future (1 week) or PCI same day.
Exclusion
Exclusion Criteria:
Subjects must NOT meet any of the following Exclusion Criteria to participate in the trial.
Severe chronic kidney disease with eGFR ≤ 20 ml/min or on dialysis
Patients with AKI within the last seven days prior screening or incipient AKI (incases, where AKI cannot be ruled out as a cause for elevated serum creatinine, arise or fall above 30% of a second serum creatinine measurement obtained within 12to 24 hours is regarded indicative of AKI).
STEMI ≤24 hours from the onset of ischemic symptoms or at any time if mechanicalcomplications of transmural infarction are present (e.g., VSD, papillary musclerupture, etc.)
Cardiogenic shock (SBP <80 mmHg for ≥30 mins and not responsive to intravenousfluids or hemodynamic deterioration for any duration requiring pressors ormechanical circulatory support, including IABP)
Cardiorespiratory arrest related to the current admission unless subject isextubated for >24 hours with full neurologic recovery and hemodynamically stable.
Platelet count <75,000 cells/mm3, bleeding diathesis or active bleeding,coagulopathy or unwilling to receive blood transfusions.
Pregnant or child-bearing potential unless negative pregnancy test within 1 week
Participation in the active treatment or follow-up phase of another clinical studyof an investigational drug or device that has not reached its primary endpoint
Any medical or psychiatric condition such as dementia, alcoholism or substance abusewhich may preclude informed consent or interfere with any of the study procedures,including follow-up visits
Any non-cardiac condition with life expectancy <1 years (e.g., cirrhosis, cancer notin remission, etc.)
Subject belongs to a vulnerable population (defined as individuals with mentaldisability, persons in nursing homes, impoverished persons, homeless persons,nomads, refugees and those permanently incapable of giving informed consent;vulnerable populations also may include members of a group with a hierarchicalstructure such as university students, subordinate hospital and laboratorypersonnel, employees of the Sponsor, members of the armed forces and persons kept indetention)
Study Design
Study Description
Connect with a study center
Department of Cardiology, Angiology and Intensive Care Medicine Campus at German Heart Center Charite
Berlin,
GermanyActive - Recruiting
Division of Cardiology, Pulmonary Disease and Vascular Medicine at University Hospital Duesseldorf
Duesseldorf, 40225
GermanyActive - Recruiting

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