Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT07444931

Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD

Led by Tampere Heart Hospital · Updated on 2026-03-03

1500

Participants Needed

3

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Ability to give informed consent
  • Imaging-confirmed diagnosis of coronary artery disease within the past 12 months via coronary angiography or contrast-enhanced coronary computed tomography
  • Presence of more than 50% stenosis and/or fractional flow reserve less than 0.8 verified by selective coronary angiography or CT, or type I myocardial infarction with atherosclerotic origin
  • Recruitment may occur during index event visits or by recalling patients diagnosed within 12 months if possible
Not Eligible

You will not qualify if you...

  • Age over 75 years
  • Significant previously treated valvular heart disease or requiring operative treatment within the next three months
  • Diagnosed severe neurodegenerative disease (ALS, myositis, multiple sclerosis, Parkinson's disease) or impaired cognitive function (MMSE less than 23)
  • Known developmental disability impairing legal ability to give written consent
  • Serious or active malignancy with an estimated life expectancy under one year
  • Inability to give written consent for any reason
  • Other significant cardiac conditions linked to fatal ventricular arrhythmia risk (e.g., ARVCD, non-ischemic dilated cardiomyopathy, hypertrophic cardiomyopathy, genetic long or short QT syndrome)
  • Other cardiac diseases with less than one year life expectancy
  • Do-Not-Resuscitate (DNR) orders
  • Previous or planned cardiac, renal, or liver transplant
  • Participation in another clinical trial involving active treatment

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Trial Site Locations

Total: 3 locations

1

The Medical Research Foundation for the Development of Infrastructure and Health Services near Hillel Yaffe Medical Center

Hadera, Israel

Actively Recruiting

2

Instituția Medico-Sanitară Publică "Institutul de Cardiologie"

Chisinau, Moldova

Actively Recruiting

3

Carol Davila University of Medicine and Pharmacy

Bucharest, Romania

Actively Recruiting

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Research Team

J

Jussi A Hernesniemi, MD, PhD

CONTACT

J

Juho T Tynkkynen, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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