Digital MEDIcal TWIN for the Prediction of Arrhythmic Sudden Cardiac Death After a Myocardial 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
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
Treatments tested in this trial
- Programmed ventricular stimulation
- Cardiac CT scan
Treatment groups
1,000 Participants
are divided into 1 treatment groupLocations
1CHU de Bordeaux, Hôpital Cardiologique du Haut-Lévêque33604, Pessac France
Sponsors and collaborators
University Hospital, Bordeaux
Lead sponsor
Source ClinicalTrials.gov