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RECRUITING
NCT07444931

Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD

Sponsor: Tampere Heart Hospital

View on ClinicalTrials.gov

Summary

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 SCD/sudden cardiac arrest (SCA) or a comparable malignant arrhythmic event (i.e., resuscitation). Secondary endpoints include other major cardiovascular events occurring during the follow-up period (such as cerebrovascular events, myocardial infarctions, revascularizations, and new arrhythmias like atrial fibrillation following procedures or after the patient has been discharged following recruitment) or the occurrence and mortality of other significant life-threatening diseases (such as cancer). Secondary endpoints also include poor success in secondary prevention, which can be assessed through completed medication purchases and the achievement of secondary prevention goals. This observational, prospective study includes collecting multimodal data from hospitals in Finland (TAUH), Israel (HYMC), Moldova (IMSP) and Romania (UMFCD). Each participating institution has followed a process structured by Tampere Heart Hospital (TAUH) for securing permissions in line with EU and national regulations.

Official title: Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD - CVDLINK Clinical Validation Study.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

1500

Start Date

2025-01-05

Completion Date

2027-12-31

Last Updated

2026-03-03

Healthy Volunteers

No

Locations (3)

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