Digital MEDIcal TWIN for the Prediction of Arrhythmic Sudden Cardiac Death After a Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Occurrence of sudden cardiac death or sustained ventricular arrhythmia
研究概览
简要总结
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%.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of ST-segment elevation myocardial infarction (STEMI) in the last 6 months
- •Signed informed consent
- •Affiliated to or beneficiary of a health insurance
排除标准
- •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
研究组 & 干预措施
Single arm
Programmed ventricular stimulation and CT scan
干预措施: Programmed ventricular stimulation (Procedure)
Single arm
Programmed ventricular stimulation and CT scan
干预措施: Cardiac CT scan (Procedure)
结局指标
主要结局
Occurrence of sudden cardiac death or sustained ventricular arrhythmia
时间窗: 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)
次要结局
- Occurrence of syncope at M60(At month 60 after enrillment)
- Occurrence of non-sustained ventricular arrhythmias at M60(At month 60 after inclusion)