Digital MEDIcal TWIN for the Prediction of Arrhythmic Sudden Cardiac Death After a Myocardial Infarction

NCT07527494 | Not Yet Recruiting

• 1 other identifier: CHUBX 2024/92
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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%.

Conditions

Sudden Cardiac Death; Myocardial Infarction

Keywords

Sudden cardiac death; Myocardial infarction; Prediction; Multiparametric model; Ventricular Arrhythmia

Outcome Measures

Primary Outcomes (1)

• 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)

  From enrollment to the end of the 60-months follow-up

Secondary Outcomes (2)

• Occurrence of syncope at M60

  At month 60 after enrillment

• Occurrence of non-sustained ventricular arrhythmias at M60

  At month 60 after inclusion

Study Arms (1)

Single arm

EXPERIMENTAL

Programmed ventricular stimulation and CT scan

Procedure: Programmed ventricular stimulation; Procedure: Cardiac CT scan

Interventions

Programmed ventricular stimulation PROCEDURE

Invasive cardiac electrophysiology (EP) study

Single arm

Cardiac CT scan PROCEDURE

Cardiac CT scan with contrast enhancement

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of ST-segment elevation myocardial infarction (STEMI) in the last 6 months
• Signed informed consent
• Affiliated to or beneficiary of a health insurance

You may not qualify if:

• Renal failure (Creatinine clearance \<30 mL/min), or a systemic illness likely to limit survival to \<1 year
• Unable to understand the nature, risks, significance and implications of the clinical investigation or unwilling to provide written informed consent
• Participant under legal protection

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux, Hôpital Cardiologique du Haut-Lévêque

Pessac, 33604, France

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis

Study Officials

• Josselin DUCHATEAU, MD

  University Hospital, Bordeaux

  STUDY DIRECTOR

Central Study Contacts

Edouard GERBAUD, MD

CONTACT

+33(0)524549188; edouard.gerbaud@chu-bordeaux.fr

Valérie BOILET

CONTACT

+33(0)524549366; valerie.boilet@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective multicenter cohort study, non-randomized, with intervention

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2034
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

FR (1)