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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%.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Programmed ventricular stimulation and CT scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Programmed ventricular stimulation | Procedure | Invasive cardiac electrophysiology (EP) study |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edouard GERBAUD, MD | Contact | +33(0)524549188 | edouard.gerbaud@chu-bordeaux.fr | |
| Valérie BOILET | Contact | +33(0)524549366 | valerie.boilet@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Josselin DUCHATEAU, MD | University Hospital, Bordeaux | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux, Hôpital Cardiologique du Haut-Lévêque | Pessac | 33604 | France |
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| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
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Prospective multicenter cohort study, non-randomized, with intervention
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| Cardiac CT scan |
| Procedure |
Cardiac CT scan with contrast enhancement |
|
| At month 60 after inclusion |
| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |