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

NCT07527494 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Bordeaux

Phase

Not applicable

Started

2026-04-15

Last updated

2026-04-14

Condition(s) studied

Sudden Cardiac DeathMyocardial Infarction

Investigational drug(s) / intervention(s)

Programmed ventricular stimulationCardiac CT scan

Programmed ventricular stimulation: Invasive cardiac electrophysiology (EP) study

Cardiac CT scan: Cardiac CT scan with contrast enhancement

Study 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%.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Occurrence of sudden cardiac death or sustained ventricular arrhythmia — 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)

Trial sites (1)

Facility	City	Region	Status
CHU de Bordeaux, Hôpital Cardiologique du Haut-Lévêque	Pessac	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07527494 on ClinicalTrials.gov ↗ ← All trials in France