Digital MEDIcal TWIN for the Prediction of Arrhythmic Sudden Cardiac Death After a Myocardial Infarction (TWIN-SCD STEMI)

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%.

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Infarction; Sudden Cardiac Death
• Intervention / Treatment: Procedure: Programmed ventricular stimulation; Procedure: Cardiac CT scan

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:

1. 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.
2. 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 Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edouard GERBAUD, MD; Phone Number: +33(0)524549188; Email: edouard.gerbaud@chu-bordeaux.fr
• Study Contact Backup: Name: Valérie BOILET; Phone Number: +33(0)524549366; Email: valerie.boilet@chu-bordeaux.fr

Study Locations

• France
  • Pessac, France, 33604
    • CHU de Bordeaux, Hôpital Cardiologique du Haut-Lévêque
    • Contact: Valérie BOILET; Phone Number: +33(0)524549366; Email: valerie.boilet@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm; Programmed ventricular stimulation and CT scan	Procedure: Programmed ventricular stimulation; Invasive cardiac electrophysiology (EP) study; Procedure: Cardiac CT scan; Cardiac CT scan with contrast enhancement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of syncope at M60	Occurrence of syncope at M60	At month 60 after enrillment
Occurrence of non-sustained ventricular arrhythmias at M60	Occurrence of non-sustained ventricular arrhythmias at M60	At month 60 after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Director: Josselin DUCHATEAU, MD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2034

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Myocardial infarction; Sudden cardiac death; Prediction; Ventricular Arrhythmia; Multiparametric model
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Death; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Heart Arrest; Death, Sudden; Pathological Conditions, Signs and Symptoms; Death, Sudden, Cardiac; Myocardial Infarction
• Other Study ID Numbers: CHUBX 2024/92

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No