CHU de Bordeaux, Hôpital Cardiologique du Haut-Lévêque
Pessac, 33604, France
NCT Number: NCT07527494
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%.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Pessac, 33604, France
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Invasive cardiac electrophysiology (EP) study
Cardiac CT scan with contrast enhancement
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)
Time frame: At month 60 after enrillment
Occurrence of syncope at M60
Time frame: At month 60 after inclusion
Occurrence of non-sustained ventricular arrhythmias at M60
Contact information is provided by the study sponsor or research team.
Edouard GERBAUD, MD
CONTACT
Valérie BOILET
CONTACT
University Hospital, Bordeaux
Other
Acronym: TWIN-SCD STEMI
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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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