Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD

NCT07444931 | Recruiting

• 1 other identifier: 101137278
• Study Type: observational
• Target: 1,500
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Coronary Arterial Disease (CAD); Sudden Cardiac Arrest; Sudden Cardiac Death

Keywords

Coronary artery disease; Sudden cardiac arrest; Sudden cardiac death; post operative atrial fibrillation; genetics; risk factors

Outcome Measures

Primary Outcomes (2)

• Incidence of Sudden Cardiac Arrest Within 12 Months

  Number of sudden cardiac arrest occurring within one year of enrollment

  1 year

• Incidence of Sudden Cardiac Death Within 12 Months

  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.

  1 year

Secondary Outcomes (3)

• Incidence of Sudden Cardiac Arrest Within 10 years after enrollment

  Ten years after enrolment

• Incidence of Sudden Cardiac Death Within 10 years after enrollment

  10 years

• Post-operative atrial fibrillation

  Within one month after CABG.

Study Arms (1)

Patients with coronary artery disease

Patients with imaging verified coronary artery disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients with coronary artery disease meeting the inclusion criteria during the recruitment period will be invited to participate

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere Heart Hospital: lead

Study Sites (3)

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

Related Links

• CVD Link project webisite

Biospecimen

Retention: SAMPLES WITH DNA

Standard blood sample analysis is done by local certified laboratories in each participating center. Sample analysis can be done later from stored samples or directly if sample storage is not feasible. All samples are analysed for standard blood work (haemoglobin, renal function, and electrolytes) and targeted for other laboratory values. Genetic testing could be performed from the stored blood samples, which may include full whole genome sequencing, standard chip technology genotyping of the human genome, RNA transcriptome analysis and metabolomics analysis using different methods such as NMR.

MeSH Terms

Conditions

Death, Sudden, Cardiac; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jussi A Hernesniemi, MD, PhD

  Tampere Heart Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jussi A Hernesniemi, MD, PhD

CONTACT

+358 04 17322932; jussi.hernesniemi@sydansairaala.fi

Juho T Tynkkynen, MD, PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary investigator

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 3, 2026
• Study Start: January 5, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-03

Locations

MO (1); IL (1); RO (1)