RecruitingNCT07444931

Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD

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


Sponsor

Tampere Heart Hospital

Enrollment

1,500 participants

Start Date

Jan 5, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at risk factors for sudden cardiac arrest — when the heart suddenly stops beating — in people who have already been diagnosed with coronary artery disease (blockages in the heart's blood vessels). The goal is to identify who is most at risk so that better prevention strategies can be developed. **You may be eligible if:** - You are between 18 and 75 years old - You have been diagnosed with coronary artery disease within the past 12 months, confirmed by imaging showing significant blockages - You are able to provide informed consent **You may NOT be eligible if:** - You are older than 75 - You have significant valve disease in your heart that requires surgery within the next 3 months - You have a serious neurological condition such as ALS, multiple sclerosis, or Parkinson's disease, or significant memory/cognitive problems - You have an active cancer with a life expectancy of less than 1 year - You have certain other serious heart conditions such as inherited arrhythmia syndromes, a specific type of heart muscle disease (ARVC, HCM), or have a Do-Not-Resuscitate order Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT07444931


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