Coronary Arterial Disease (CAD)SCARNCT07444931
Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD
An observational study of Coronary Arterial Disease (CAD) and Sudden Cardiac Arrest, run by Tampere Heart Hospital at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Arterial Disease (CAD), Sudden Cardiac Arrest, Sudden Cardiac Death
- How many people
- 1,500 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 5 Jan 2025to 31 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients with coronary artery disease meeting the inclusion criteria during the recruitment period will be invited to participate
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Juho T Tynkkynen, MD, PhD contact
3 sites in 3 countries
Israel1 site, 1 recruiting
- Recruiting
The Medical Research Foundation for the Development of Infrastructure and Health Services near Hillel Yaffe Medical Center
Hadera
Ofer Kobo, MD, PhD, oferk@hymc.gov.il
Ofer Kobo, MD, PhD
Moldova1 site, 1 recruiting
- Recruiting
Instituția Medico-Sanitară Publică "Institutul de Cardiologie"
Chisinau
Marcel Abras, MD, +373 22 727 511, marcel.abras@usmf.md
Catherine Beiu, MD, +373 22 727 511, beiucatherine@gmail.com
Romania1 site, 1 recruiting
- Recruiting
Carol Davila University of Medicine and Pharmacy
Bucharest
Catalina L Andrei, MD, +40 21 334 3025, catalina.andrei@umfcd.ro
Maria-Alexandra Ciuca-Pana, MD
About this study
Official title: Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD - CVDLINK Clinical Validation Study.
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.
Read more
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.
Read the detailed description
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.
- Keywords
- Coronary artery disease, Sudden cardiac arrest, Sudden cardiac death, post operative atrial fibrillation, genetics, risk factors
- Medical subject headings
- Death, Sudden, Cardiac, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with coronary artery disease | Patients with imaging verified coronary artery disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Sudden Cardiac Arrest Within 12 Months
Number of sudden cardiac arrest occurring within one year of enrollment
Measured: 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.
Measured: 1 year
Secondary outcomes (3)
Incidence of Sudden Cardiac Arrest Within 10 years after enrollment
Sudden cardiac arrest at any point after enrolment
Measured: 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.
Measured: 10 years
Post-operative atrial fibrillation
Atrial Fibrillation occurring after CABG
Measured: Within one month after CABG.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start5 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tampere Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jussi Hernesniemi, Tampere Heart Hospital
- Investigators
- Jussi A Hernesniemi, MD, PhD, Principal investigator, Tampere Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444931
- Sponsor's protocol ID
- 101137278
- Other IDs
- 101137278
- Acronym
- SCAR
- Status last verified
- Aug 2026
- First submitted
- 24 Feb 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Sudden Cardiac Arrest Risk Factors in Patients With CAD - CVDLINK Clinical Validation Study.
- ClinicalTrials.gov ID
- NCT07444931
- Acronym / sponsor ID
- SCAR / 101137278
- Keywords
- Coronary artery disease, Sudden cardiac arrest, Sudden cardiac death, post operative atrial fibrillation, genetics, risk factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Tampere Heart HospitalUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with coronary artery disease | – | –Patients with imaging verified coronary artery disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients with coronary artery disease meeting the inclusion criteria during the recruitment period will be invited to participate
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Sudden Cardiac Arrest Within 12 Months
Time frame: 1 year
Number of sudden cardiac arrest occurring within one year of enrollment
Incidence of Sudden Cardiac Death Within 12 Months
Time frame: 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.
3 secondary outcomes
Incidence of Sudden Cardiac Arrest Within 10 years after enrollment
Time frame: Ten years after enrolment
Incidence of Sudden Cardiac Death Within 10 years after enrollment
Time frame: 10 years
Post-operative atrial fibrillation
Time frame: Within one month after CABG.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- CVD Link project webisiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juho T Tynkkynen, MD, PhD contact
Jussi A Hernesniemi, MD, PhD principal investigator
Tampere Heart Hospital
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arterial Disease (CAD) and Sudden Cardiac Arrest, run by Tampere Heart Hospital at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel, Moldova, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jussi A Hernesniemi, MD, PhD (+358 04 17322932, jussi.hernesniemi@sydansairaala.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Sudden Cardiac Arrest Within 12 Months (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.