Predicting sudden cardiac arrest risk in people with coronary artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: jussi.hernesniemi@sydansairaala.fi
• Phone: +358 04 17322932

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Identifying risk factors for sudden cardiac arrest in coronary artery disease patients

  This study is trying to find out what clinical and genetic factors might increase the risk of sudden cardiac arrest in people with coronary artery disease.

  Recruiting Tampere Heart Hospital · Tampere, Pirkanmaa · NCT06804499

• Genetic assessment of young athletes who experience sudden cardiac arrest during sports

  This study looks at young athletes aged 12 to 35 who have had sudden cardiac arrest during sports to see if genetic factors played a role and to help prevent similar events in others.

  Recruiting at 15 sites Rennes University Hospital · Nîmes, France and 25 other locations · NCT06642168

• Registry and biobank for arrhythmogenic ventricular cardiomyopathy

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  Recruiting at 2 sites Mayo Clinic · Rochester, Minnesota and 1 other locations · NCT03049254

• Red grape juice and metabolism in men with coronary disease

  Researchers will test whether daily red grape juice changes the blood metabolite profile in men with chronic coronary artery disease.

  Recruiting University of Sao Paulo General Hospital · São Paulo, São Paulo · NCT07777341

• Edoxaban vs. Apixaban in AF with CAD: Net Benefit

  This trial tests whether edoxaban-based therapy provides a similar or better overall benefit than apixaban-based therapy for stroke prevention and major bleeding in adults with atrial fibrillation and coronary artery disease.

  Recruiting Phase 4 Samsung Medical Center · Seoul · NCT07753200

• Revascularization of Calcified Coronary Arteries

  This study tests whether measuring blood flow and pressure before and after ballooning or stenting of calcified coronary arteries can help predict how well the procedure will work for adults with heart disease.

  Recruiting Aalborg University Hospital · Aalborg · NCT07724184

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.