Sudden Cardiac DeathTWIN-SCD STEMINCT07527494
Digital MEDIcal TWIN for the Prediction of Arrhythmic Sudden Cardiac Death After a Myocardial Infarction
A study testing Programmed ventricular stimulation and Cardiac CT scan in people with Sudden Cardiac Death and Myocardial Infarction, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
TWIN-SCD STEMI is a multicentric prospective, non-randomized pilot study designed to establish a multiparametric model for predicting life-threatening ventricular arrhythmias in patients experiencing their first myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Death, Myocardial Infarction
- What is being tested?
- Programmed ventricular stimulation and Cardiac CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2026to 31 Dec 2034
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of ST-segment elevation myocardial infarction (STEMI) in the last 6 months
- Signed informed consent
- Affiliated to or beneficiary of a health insurance
Who cannot join
- Renal failure (Creatinine clearance <30 mL/min), or a systemic illness likely to limit survival to <1 year
- Women who are pregnant, lactating, or who are planning to become pregnant within 2 years following her inclusion
- Unable to understand the nature, risks, significance and implications of the clinical investigation or unwilling to provide written informed consent
- Participant under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Bordeaux, Hôpital Cardiologique du Haut-Lévêque
Pessac, 33604
Valérie BOILET, +33(0)524549366, valerie.boilet@chu-bordeaux.fr
About this study
TWIN-SCD STEMI is a multicentric prospective, non-randomized pilot study designed to establish a multiparametric model for predicting life-threatening ventricular arrhythmias in patients experiencing their first myocardial infarction. The primary objective of the study is to develop an algorithm with superior predictive performance (sensitivity and specificity) compared to the currently used criterion for the implantation of a cardiac defibrillator, which is a left ventricular ejection fraction (LVEF) of less than 35%.
Read the detailed description
Sudden cardiac death (SCD) accounts for 10% of deaths in the general population, with 80% of these cases caused by malignant ventricular arrhythmias. These arrhythmias predominantly occur in individuals with cardiomyopathies, especially those with a history of myocardial infarction (MI). Currently, SCD prevention after a first MI relies on risk stratification based on myocardial contractility, specifically indicating prophylactic cardiac defibrillator implantation for patients with a left ventricular ejection fraction (LVEF) ≤ 35%. However, this approach is insufficient due to two main reasons:
- Among patients with LVEF ≤ 35%, only a minority (2-5% per year) will experience arrhythmias and benefit from defibrillator implantation, while all face potential serious complications from the device.
- Most SCD cases occur in patients with LVEF > 35%. Although these patients have a lower individual arrhythmia risk (1-2% per year), they represent a substantially larger population at risk, with no stratification within this group.
Emerging evidence suggests that additional parameters (biological markers, cardiac imaging, and electrophysiologic data) can better characterize the arrhythmogenic substrate in patients after their first MI, enabling improved identification of those at risk for arrhythmic SCD.
The primary objective of this study is to develop a multiparametric model that outperforms the current criterion (LVEF < 35%) for predicting the need for cardiac defibrillator implantation in patients presenting with a first myocardial infarction. Clinical data, biological data, imaging data of the scar using CT scan and MRI, and electrophysiological data from 12-lead ECG, 24-hour Holter ECG will be used to establish this multiparametric model. The model will be compared to the current criteria for predicting the occurrence of malignant ventricular arrhythmias (spontaneous during the one-year follow-up or induced by an electrophysiology study at 12 months and 24 months) in this cohort.
- Conditions
- Sudden Cardiac Death, Myocardial Infarction
- Being tested
- Programmed ventricular stimulation, Cardiac CT scan
- Keywords
- Sudden cardiac death, Myocardial infarction, Prediction, Multiparametric model, Ventricular Arrhythmia
- 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.
Programmed ventricular stimulationProcedure or surgery
Invasive cardiac electrophysiology (EP) study
Cardiac CT scanProcedure or surgery
Cardiac CT scan with contrast enhancement
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Programmed ventricular stimulation and CT scan Receives: Procedure: Programmed ventricular stimulation; Procedure: Cardiac CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of sudden cardiac death or sustained ventricular arrhythmia
Event defined by occurrence of sudden cardiac death or appriopriate ICD shock delivery or sustained ventricular arrhythmia (lasting more than 30 seconds)
Measured: From enrollment to the end of the 60-months follow-up
Secondary outcomes (2)
Occurrence of syncope at M60
Occurrence of syncope at M60
Measured: At month 60 after enrillment
Occurrence of non-sustained ventricular arrhythmias at M60
Occurrence of non-sustained ventricular arrhythmias at M60
Measured: At month 60 after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion31 Dec 2033 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective multicenter cohort study, non-randomized, with intervention
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josselin DUCHATEAU, MD, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527494
- Sponsor's protocol ID
- CHUBX 2024/92
- Acronym
- TWIN-SCD STEMI
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital MEDIcal TWIN for the Prediction of Arrhythmic Sudden Cardiac Death After a Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07527494
- Acronym / sponsor ID
- TWIN-SCD STEMI / CHUBX 2024/92
- Conditions
- Sudden Cardiac Death, Myocardial Infarction
- Keywords
- Sudden cardiac death, Myocardial infarction, Prediction, Multiparametric model, Ventricular Arrhythmia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2033 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 14 Apr 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.
TWIN-SCD STEMI is a multicentric prospective, non-randomized pilot study designed to establish a multiparametric model for predicting life-threatening ventricular arrhythmias in patients experiencing their first myocardial infarction. The primary objective of the study is to develop an algorithm with superior predictive performance (sensitivity and specificity) compared to the currently used criterion for the implantation of a cardiac defibrillator, which is a left ventricular ejection fraction (LVEF) of less than 35%.
Detailed description
Sudden cardiac death (SCD) accounts for 10% of deaths in the general population, with 80% of these cases caused by malignant ventricular arrhythmias. These arrhythmias predominantly occur in individuals with cardiomyopathies, especially those with a history of myocardial infarction (MI). Currently, SCD prevention after a first MI relies on risk stratification based on myocardial contractility, specifically indicating prophylactic cardiac defibrillator implantation for patients with a left ventricular ejection fraction (LVEF) ≤ 35%. However, this approach is insufficient due to two main reasons:
- Among patients with LVEF ≤ 35%, only a minority (2-5% per year) will experience arrhythmias and benefit from defibrillator implantation, while all face potential serious complications from the device.
- Most SCD cases occur in patients with LVEF > 35%. Although these patients have a lower individual arrhythmia risk (1-2% per year), they represent a substantially larger population at risk, with no stratification within this group.
Emerging evidence suggests that additional parameters (biological markers, cardiac imaging, and electrophysiologic data) can better characterize the arrhythmogenic substrate in patients after their first MI, enabling improved identification of those at risk for arrhythmic SCD.
The primary objective of this study is to develop a multiparametric model that outperforms the current criterion (LVEF < 35%) for predicting the need for cardiac defibrillator implantation in patients presenting with a first myocardial infarction. Clinical data, biological data, imaging data of the scar using CT scan and MRI, and electrophysiological data from 12-lead ECG, 24-hour Holter ECG will be used to establish this multiparametric model. The model will be compared to the current criteria for predicting the occurrence of malignant ventricular arrhythmias (spontaneous during the one-year follow-up or induced by an electrophysiology study at 12 months and 24 months) in this cohort.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective multicenter cohort study, non-randomized, with intervention
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Procedure: Programmed ventricular stimulation, Procedure: Cardiac CT scanProgrammed ventricular stimulation and CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of ST-segment elevation myocardial infarction (STEMI) in the last 6 months
- Signed informed consent
- Affiliated to or beneficiary of a health insurance
Key exclusion criteria (4 listed)
- Renal failure (Creatinine clearance <30 mL/min), or a systemic illness likely to limit survival to <1 year
- Women who are pregnant, lactating, or who are planning to become pregnant within 2 years following her inclusion
- Unable to understand the nature, risks, significance and implications of the clinical investigation or unwilling to provide written informed consent
- Participant under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Programmed ventricular stimulationInvasive cardiac electrophysiology (EP) study | Procedure or surgery | Single arm |
| Cardiac CT scanCardiac CT scan with contrast enhancement | Procedure or surgery | Single arm |
Primary outcome
Occurrence of sudden cardiac death or sustained ventricular arrhythmia
Time frame: From enrollment to the end of the 60-months follow-up
Event defined by occurrence of sudden cardiac death or appriopriate ICD shock delivery or sustained ventricular arrhythmia (lasting more than 30 seconds)
2 secondary outcomes
Occurrence of syncope at M60
Time frame: At month 60 after enrillment
Occurrence of non-sustained ventricular arrhythmias at M60
Time frame: At month 60 after inclusion
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 14 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Josselin DUCHATEAU, MD study director
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Programmed ventricular stimulation and Cardiac CT scan in people with Sudden Cardiac Death and Myocardial Infarction, run by University Hospital, Bordeaux at 1 site in France.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 14 Apr 2026. 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 France. 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 Edouard GERBAUD, MD (+33(0)524549188, edouard.gerbaud@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of sudden cardiac death or sustained ventricular arrhythmia (time frame: From enrollment to the end of the 60-months follow-up). 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 14 Apr 2026.