An observational study in Coronary Arterial Disease (CAD), Sudden Cardiac Arrest and Sudden Cardiac Death, sponsored by Tampere Heart Hospital. Recruiting at 3 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Tampere Heart Hospital · Observational
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.
Sudden cardiac arrest (SCA) and sudden cardiac death (SCD) are most commonly caused by malignant ventricular arrhythmias in patients with underlying coronary artery disease (CAD). Current risk stratification strategies, largely based on left ventricular ejection fraction, identify only a minority of patients who will experience SCA/SCD. Traditional cardiovascular risk factors lack sufficient specificity for arrhythmic death and are frequently associated with competing non-arrhythmic mortality. Improved, biologically informed risk prediction tools are therefore needed.
This prospective, multicenter observational study is designed to validate and refine multimodal risk prediction models for SCA/SCD in patients with imaging-confirmed CAD. Recruitment is planned between 2024 and 2026 across centers in Finland, Israel, Romania, and Moldova, with long-term follow-up extending up to 10-15 years. The anticipated total sample size is approximately 1,500-2,000 participants.
Baseline data collection includes comprehensive clinical information, imaging findings, electrocardiographic parameters, circulating biomarkers, lifestyle factors, and genetic samples. Imaging and biosignal data are stored in standardized digital formats to enable advanced analyses. Biological samples are stored for future genomic (including full genome sequencing and RNA expression data) and molecular analyses. All participants receive guideline-directed care; no experimental interventions are introduced.
The primary objective is to evaluate the performance of an AI-based risk assessment framework in identifying CAD patients at elevated risk of SCA/SCD, particularly during the first year after coronary angiography, and to assess its long-term predictive performance. Additional objectives include validation of previously reported arrhythmic risk markers, development of updated multivariable risk models, and evaluation of postoperative atrial fibrillation risk in patients undergoing coronary artery bypass grafting.
Primary endpoints include incident SCA, SCD, or equivalent malignant ventricular arrhythmic events. Secondary endpoints include major cardiovascular events, device therapies, heart failure hospitalization, new-onset atrial fibrillation, and all-cause mortality. Endpoints are adjudicated locally by blinded physician panels based on registry data and clinical documentation, with competing causes of death taken into account in the analyses.
Data analysis focuses on evaluating associations between predefined exposure variables and clinical outcomes, validating predictive models across participating centers, and applying federated analytical approaches when appropriate to enable cross-population validation without sharing individual-level data.
The study is observational and does not alter patient management. All procedures comply with applicable regulatory and ethical requirements. Genetic and exploratory biomarker analyses are conducted for research purposes only and are not returned to participants.
363 studies on the registry are indexed under Death, Sudden, Cardiac; 84 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 449 across 202 observational studies indexed under Death, Sudden, Cardiac.
Browse Death, Sudden, Cardiac studies →Tampere Heart Hospital is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive patients with coronary artery disease meeting the inclusion criteria during the recruitment period will be invited to participate
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with imaging verified coronary artery disease
Incidence of Sudden Cardiac Arrest Within 12 Months
Number of sudden cardiac arrest occurring within one year of enrollment
Time frame: 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.
Time frame: 1 year
Incidence of Sudden Cardiac Arrest Within 10 years after enrollment
Sudden cardiac arrest at any point after enrolment
Time frame: Ten years after enrolment
Incidence of Sudden Cardiac Death Within 10 years after enrollment
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.
Time frame: 10 years
Post-operative atrial fibrillation
Atrial Fibrillation occurring after CABG
Time frame: Within one month after CABG.
Plan to share: Undecided — The data collected in the SCAR is used primarily for EU funded project CVD LINK. After CVD Link each participating center will decide of the use of the data based on local legislation and data protection regulations.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2027, 35 months after the start.
Of 69 non-industry observational studies under Death, Sudden, Cardiac, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 42. This study's planned 35 months is below that.
Counting every sponsor, half of 85 studies reached it within 63 months; a quarter within 40.
How these figures are worked out, and which studies are left out of them.
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Tampere Heart Hospital