Sudden Death, CardiacNCT07137936
Cardiac Magnetic Resonance - PROgnostic HEart Scar for Sudden Cardiac Death Prediction StudY
An observational study of Sudden Death, Cardiac and Myocardial Scarring, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The purpose of this observational study is to investigate whether myocardial scar characteristics assessed by cardiac magnetic resonance (CMR) can predict the risk of out-of-hospital sudden cardiac death (SCD) after myocardial infarction (MI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sudden Death, Cardiac, Myocardial Scarring, Myocardial Infarction (MI)
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2036
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese patients with myocardial infarction (MI).
Who may be able to join
- Age between 18 and 80 years.
- Completion of cardiac magnetic resonance (CMR) imaging at Anzhen Hospital during the stable phase (≥1 month) following an acute myocardial infarction (MI).
Who cannot join
- Prior implantation of an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) before the index MI.
- Pre-existing diagnosis of a primary arrhythmia syndrome (e.g., long QT syndrome, Brugada syndrome) before the index MI.
- Concurrent end-stage disease (e.g., advanced malignancy) directly resulting in an estimated life expectancy of less than one year.
- History of established non-ischemic cardiomyopathy (e.g., dilated, hypertrophic, or restrictive cardiomyopathy) before the index MI.
- Significant concomitant valvular heart disease. Status post mechanical heart valve replacement.
- Patients refuse to be followed up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing
Wangyang Yang, +86 64456214, 64410703@163.com
About this study
Official title: Comprehensive Cardiac Magnetic Resonance Imaging Evaluation of Myocardial Scar for Predicting Sudden Cardiac Death Post Myocardial Infarction
The purpose of this observational study is to investigate whether myocardial scar characteristics assessed by cardiac magnetic resonance (CMR) can predict the risk of out-of-hospital sudden cardiac death (SCD) after myocardial infarction (MI). It aims to answer two primary questions:
What is the association between CMR-assessed myocardial scar and post-MI SCD? Can we develop an imaging-clinical multimodal risk score for post-MI SCD? Participants included in this study had previously undergone CMR imaging during the stable phase following their MI as part of their prior clinical care. Prognostic data for these participants are collected through clinic visits and telephone follow-up.
Read the detailed description
Sudden cardiac death (SCD) remains a leading cause of mortality post-myocardial infarction (MI). Current risk stratification relying primarily on left ventricular ejection fraction (LVEF ≤35%) for implantable cardioverter-defibrillator (ICD) therapy is inadequate, as many SCD events occur in patients with LVEF >35%. Myocardial scar characteristics assessed by cardiac magnetic resonance (CMR), particularly late gadolinium enhancement (LGE), show promise for improved arrhythmic risk prediction but require robust validation. This study aims to develop and validate a multimodal clinical-CMR risk prediction model integrating comprehensive scar characterization to better identify high-risk post-MI patients who may benefit from ICD therapy, optimizing prevention strategies and resource utilization.
This single-center, ambispective cohort study comprises two phases. Phase 1 (Retrospective): Patients treated for myocardial infarction (MI) at our institution between 2015 and 2025 were screened retrospectively. Those who underwent CMR imaging at least one month post-MI were included. Baseline clinical characteristics and detailed CMR findings were collected. Prognostic data for these patients were retrospectively gathered through January 2026.
Phase 2 (Prospective): Prospective collection of prognostic data for the enrolled cohort will continue from 2026 through 2036. Follow-up will be conducted primarily via clinic visits and telephone interviews at 6-month intervals.
Endpoint Definitions:
Primary Endpoint: Sudden cardiac death (SCD)-equivalent events, encompassing:
SCD events;Aborted SCD events (successful resuscitation from cardiac arrest or ventricular arrhythmia);Appropriate implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) therapies for terminating ventricular tachyarrhythmias.
Secondary Endpoints:
Include all-cause mortality, cardiovascular mortality, heart failure rehospitalization, recurrent myocardial infarction, and composite endpoints thereof.
- Keywords
- sudden cardiac death, myocardial infarction, myocardial scar, Cardiac magnetic resonance imaging
- Medical subject headings
- Death, Sudden, Cardiac, Myocardial Infarction
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 |
|---|---|---|
| myocardial infarction patients. | Participants included in this study had previously undergone CMR imaging during the stable phase following their MI as part of their prior clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sudden cardiac death (SCD)-equivalent events
Primary Endpoint: Sudden cardiac death (SCD)-equivalent events, encompassing:
SCD events: cardiac death occured in a short time period (2 hour of symptom), which were assessed by two separated doctors from the central laboratory.
Aborted SCD events (successful resuscitation from cardiac arrest or ventricular arrhythmia): patients with ventricular tachycardia, ventricular fibrillation or sudden cardiac arrest who were saved by cardio-pulmonary resuscitation and electric defibrillation.
Appropriate implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) therapies for terminating ventricular tachyarrhythmias: Shock related events were analyzed by two separated experienced electrophysiology doctor,to identify if the shock is delivered by sustained ventricular tachycardia, ventricular fibrillation and sudden cardiac death.
Measured: 10-20 years
Secondary outcomes (1)
Secondary Outcome
Include all-cause mortality, cardiovascular mortality, heart failure rehospitalization, recurrent myocardial infarction, and composite endpoints thereof.
Measured: 10-20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2036 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Death, CardiacStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137936
- Sponsor's protocol ID
- 2025AZC2006
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Cardiac Magnetic Resonance Imaging Evaluation of Myocardial Scar for Predicting Sudden Cardiac Death Post Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07137936
- Acronym / sponsor ID
- 2025AZC2006
- Keywords
- sudden cardiac death, myocardial infarction, myocardial scar, Cardiac magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2036 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 22 Aug 2025 (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.
The purpose of this observational study is to investigate whether myocardial scar characteristics assessed by cardiac magnetic resonance (CMR) can predict the risk of out-of-hospital sudden cardiac death (SCD) after myocardial infarction (MI). It aims to answer two primary questions:
What is the association between CMR-assessed myocardial scar and post-MI SCD? Can we develop an imaging-clinical multimodal risk score for post-MI SCD? Participants included in this study had previously undergone CMR imaging during the stable phase following their MI as part of their prior clinical care. Prognostic data for these participants are collected through clinic visits and telephone follow-up.
Detailed description
Sudden cardiac death (SCD) remains a leading cause of mortality post-myocardial infarction (MI). Current risk stratification relying primarily on left ventricular ejection fraction (LVEF ≤35%) for implantable cardioverter-defibrillator (ICD) therapy is inadequate, as many SCD events occur in patients with LVEF >35%. Myocardial scar characteristics assessed by cardiac magnetic resonance (CMR), particularly late gadolinium enhancement (LGE), show promise for improved arrhythmic risk prediction but require robust validation. This study aims to develop and validate a multimodal clinical-CMR risk prediction model integrating comprehensive scar characterization to better identify high-risk post-MI patients who may benefit from ICD therapy, optimizing prevention strategies and resource utilization.
This single-center, ambispective cohort study comprises two phases. Phase 1 (Retrospective): Patients treated for myocardial infarction (MI) at our institution between 2015 and 2025 were screened retrospectively. Those who underwent CMR imaging at least one month post-MI were included. Baseline clinical characteristics and detailed CMR findings were collected. Prognostic data for these patients were retrospectively gathered through January 2026.
Phase 2 (Prospective): Prospective collection of prognostic data for the enrolled cohort will continue from 2026 through 2036. Follow-up will be conducted primarily via clinic visits and telephone interviews at 6-month intervals.
Endpoint Definitions:
Primary Endpoint: Sudden cardiac death (SCD)-equivalent events, encompassing:
SCD events;Aborted SCD events (successful resuscitation from cardiac arrest or ventricular arrhythmia);Appropriate implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) therapies for terminating ventricular tachyarrhythmias.
Secondary Endpoints:
Include all-cause mortality, cardiovascular mortality, heart failure rehospitalization, recurrent myocardial infarction, and composite endpoints thereof.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| myocardial infarction patients. | – | –Participants included in this study had previously undergone CMR imaging during the stable phase following their MI as part of their prior clinical care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese patients with myocardial infarction (MI).
Key inclusion criteria (2 listed)
- Age between 18 and 80 years.
- Completion of cardiac magnetic resonance (CMR) imaging at Anzhen Hospital during the stable phase (≥1 month) following an acute myocardial infarction (MI).
Key exclusion criteria (6 listed)
- Prior implantation of an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) before the index MI.
- Pre-existing diagnosis of a primary arrhythmia syndrome (e.g., long QT syndrome, Brugada syndrome) before the index MI.
- Concurrent end-stage disease (e.g., advanced malignancy) directly resulting in an estimated life expectancy of less than one year.
- History of established non-ischemic cardiomyopathy (e.g., dilated, hypertrophic, or restrictive cardiomyopathy) before the index MI.
- Significant concomitant valvular heart disease. Status post mechanical heart valve replacement.
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
Sudden cardiac death (SCD)-equivalent events
Time frame: 10-20 years
Primary Endpoint: Sudden cardiac death (SCD)-equivalent events, encompassing: SCD events: cardiac death occured in a short time period (2 hour of symptom), which were assessed by two separated doctors from the central laboratory. Aborted SCD events (successful resuscitation from cardiac arrest or ventricular arrhythmia): patients with ventricular tachycardia, ventricular fibrillation or sudden cardiac arrest who were saved by cardio-pulmonary resuscitation and electric defibrillation. Appropriate implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) therapies for terminating ventricular tachyarrhythmias: Shock related events were analyzed by two separated experienced electrophysiology doctor,to identify if the shock is delivered by sustained ventricular tachycardia, ventricular fibrillation and sudden cardiac death.
1 secondary outcome
Secondary Outcome
Time frame: 10-20 years
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 22 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Death, Cardiac and Myocardial Scarring, run by Beijing Anzhen Hospital at 1 site in China.
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 2 inclusion and 6 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 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sudden cardiac death (SCD)-equivalent events (time frame: 10-20 years). 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 22 Aug 2025.