Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD

Condition(s) studied

Study 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

Primary outcome measure(s)

• Incidence of Sudden Cardiac Arrest Within 12 Months — 1 year
  Number of sudden cardiac arrest occurring within one year of enrollment
• Incidence of Sudden Cardiac Death Within 12 Months — 1 year
  The number of sudden deaths of cardiac origin occurring within 1 year of enrollment. These events are defined by ESC/AHA definitions but also inlcuding events that would have resulted in SCD had not successfully resuscitated by bystanders or emergency personnel if the event was witnessed.

Trial sites (3)

Other trials for the same condition