Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD (NCT07444931) | Clinical Trial Compass
RecruitingNot Applicable
Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD
Israel, Moldova, Romania1,500 participantsStarted 2025-01-05
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-Resuscit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Sudden Cardiac Arrest Within 12 Months
Timeframe: 1 year
2
Incidence of Sudden Cardiac Death Within 12 Months