Predicting sudden cardiac arrest risk in people with coronary artery disease

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

This project will try to see if combining genetics, ECGs, blood biomarkers, imaging, and psychosocial information can predict which people with coronary artery disease are most likely to have sudden cardiac arrest.

Quick facts

• Study type: Observational
• Enrollment: 1500 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tampere Heart Hospital (Academic / other)
• Locations: 3 sites (Hadera and 2 other locations)
• Trial ID: NCT07444931 on ClinicalTrials.gov

What this trial studies

This prospective, multicenter observational cohort will enroll about 1,500–2,000 adults with imaging-confirmed coronary artery disease across centers in Finland, Israel, Romania, and Moldova, with planned follow-up up to 10–15 years. Baseline data collection includes clinical history, standardized imaging, electrocardiographic parameters, circulating biomarkers, lifestyle and psychosocial measures, and genetic samples stored for future sequencing and molecular analyses. The project will validate and refine multimodal risk-prediction models for sudden cardiac arrest and sudden cardiac death using standardized digital data and advanced analytics. No experimental interventions are given and all participants receive guideline-directed care.

Who should consider this trial

Good fit: Adults aged 18–75 who can give informed consent and have imaging-confirmed coronary artery disease within the past 12 months (≥50% stenosis or FFR <0.8 on angiography/contrast CT, or type I atherosclerotic MI) are ideal candidates.

Not a fit: Patients older than 75, those with significant valvular disease requiring imminent intervention, or those with severe neurodegenerative disease or major cognitive impairment were excluded and are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could identify a subgroup of CAD patients who might benefit from preventive implantable cardioverter-defibrillators, reducing sudden deaths.

How similar studies have performed: Prior approaches using left ventricular ejection fraction, single biomarkers, or ECG features have had limited specificity for SCD, while recent multimodal genomic and imaging strategies are promising but not yet validated in large prospective cohorts.

Eligibility criteria

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

Where this trial is running

Hadera and 2 other locations

• The Medical Research Foundation for the Development of Infrastructure and Health Services near Hillel Yaffe Medical Center — Hadera, Israel (Recruiting)
• Instituția Medico-Sanitară Publică "Institutul de Cardiologie" — Chisinau, Moldova (Recruiting)
• Carol Davila University of Medicine and Pharmacy — Bucharest, Romania (Recruiting)

Study contacts

• Principal investigator: Jussi A Hernesniemi, MD, PhD — Tampere Heart Hospital
• Study coordinator: Jussi A Hernesniemi, MD, PhD

Conditions Coronary Arterial Disease; Sudden Cardiac Arrest; Sudden Cardiac Death; Coronary artery disease; Sudden cardiac arrest; Sudden cardiac death; post operative atrial fibrillation; genetics