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NCT Number: NCT07527494

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

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%.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Programmed ventricular stimulation

Procedure

Invasive cardiac electrophysiology (EP) study

Cardiac CT scan

Procedure

Cardiac CT scan with contrast enhancement

Primary outcomes

  1. 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)

Secondary outcomes

  1. Occurrence of syncope at M60

    Time frame: At month 60 after enrillment

    Occurrence of syncope at M60

  2. Occurrence of non-sustained ventricular arrhythmias at M60

    Time frame: At month 60 after inclusion

    Occurrence of non-sustained ventricular arrhythmias at M60

Study contacts

Contact information is provided by the study sponsor or research team.

Edouard GERBAUD, MD

CONTACT

[email protected]

+33(0)524549188

Valérie BOILET

CONTACT

[email protected]

+33(0)524549366

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: TWIN-SCD STEMI

Important dates

Study start
2026
Primary completion
2033
Study completion
2034
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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