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Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD

Recruitingn/aAges 18 Years - 75 YearsAllTampere Heart Hospital
NCT07444931 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Long-term sudden cardiac death (abbreviation: SCAR) focuses on improving the predictability of sudden cardiac death (SCD) in patients diagnosed with coronary artery disease. The aim of the study is to determine the predictive value of measurable biological variables (including genetic factors, cardiac electrical activity, biological markers measured from circulation, and coronary artery anatomy) as well as the patients' psychosocial factors in predicting SCDs. The purpose of this study is the identification of a subgroup of coronary artery disease patients at sufficiently high risk in whom it may be possible to prevent sudden cardiac arrests and subsequent deaths using implantable cardioverter-defibrillators. The study is intended to establish a clear foundation for future interventional studies targeting high-risk coronary artery disease patients. The primary endpoint of the study is

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years old * Ability to give informed consent * Imaging confirmed diagnosis within the past 12 months (coronary artery angiography or contrast enhanced coronary computed tomography) •\>50% of stenosis and/or fractional flow-reserve \<0.8 verified by selective coronary angiography or by contrast enhanced coronary computed tomography (CT) or type I MI with atherosclerotic origin (despite stenosis percentage) * Patients may be recruited during index event visit (out-patient clinic visit, invasive procedure, hospitalization) (or if logistically possible recall patients previously diagnosed within 12 months) Exclusion Criteria: * Age \> 75 years of age * Clinically significant previously treated valvular heart disease or requiring operative (surgical or endovascular) treatment within following three months * Diagnosed severe neurodegenerative disease (ALS, myositis, multiple sclerosis, or Parkinson's disease) or known impaired cognitive function (MMSE \<23) * Known developmental disability impairing legal ability to give written consent * Serious/active malignancy with possibly reduced life expectancy of \<1 year (estimated by a physician) * Inability to give written consent for some other reason * Other significant cardiac condition severely linked to the risk of fatal ventricular arrhythmia (for example ARVCD, non-ischemic DCM, HCM or genetic long or short QT syndrome) * Other cardiac disease with \<1 years of life expectancy * Do-Not-Resuscitate (DNR) order made due to any reason * Previously done or planned cardiac, renal, or liver transplant * Participation in another clinical trial where the active treatment
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What it tests

  • Not listed
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Where

3 sites
The Medical Research Foundation for the Development of Infrastructure and Health Services near Hillel Yaffe Medical Center
Hadera, Israel
Instituția Medico-Sanitară Publică "Institutul de Cardiologie"
Chisinau, Moldova
Carol Davila University of Medicine and Pharmacy
Bucharest, Romania
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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