Health TrialsbyHealthPanel

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

ConditionsSudden Cardiac DeathMyocardial Infarction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

History of ST-segment elevation myocardial infarction (STEMI) in the last 6 months

Signed informed consent

Affiliated to or beneficiary of a health insurance

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Programmed ventricular stimulation

    Procedure/Surgery

    Invasive cardiac electrophysiology (EP) study

  • Cardiac CT scan

    Procedure/Surgery

    Cardiac CT scan with contrast enhancement

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Single armExperimental treatment 2 interventions

Trial outcomes

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)

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

Secondary outcomes

1

Occurrence of syncope at M60

Occurrence of syncope at M60

Time frame
At month 60 after enrillment
2

Occurrence of non-sustained ventricular arrhythmias at M60

Occurrence of non-sustained ventricular arrhythmias at M60

Time frame
At month 60 after inclusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Bordeaux

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: