Primary Prevention ICD Implantation in STEMI With Severe Left Ventricular Dysfunction : Input of Early Cardiac MRI in Order to Predict Left Ventricular Recovery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Mesure of ejection fraction and regional wall motion and thickening
研究概览
简要总结
Patients presenting with STEMI and late revascularization can suffer from severe left ventricular dysfunction. Midterm and longterm mortality can be determined by the risk of fatal ventricular arrythmias. For this specific population, ESC guidelines currently recommend a waiting period of up to 40 days after a STEMI with severe left ventricular dysfunction before considering ICD implantation for primary prevention of sudden death.This delay is allocated to judge left ventricular recovery.
This study aims to see whether early cardiac MRI with specific sequences can help predict which patients will most probably not recover their left ventricular function and benefit from earlier ICD implantation.
详细描述
ST segment elevation myocardial infarction represent 120 000 annual cases in France. Although its mortality has been drastically reduced by primary percutaneous coronary angioplasty (PCI), its midterm and longterm outcome in patients presenting initially with severe left ventricular (LV) dysfunction depends on the risks of heart failure and sudden death by malignant ventricular arrhythmias.
Many clinical studies such as MADIT I and II, MUSTT and DINAMIT have participated in defining which patients should benefit from ICD implantation. These studies were based on evaluation of the LV ejection fraction (LVEF) and of the risk of arrhythmia (by electrophysiology or holter recordings).
However, ESC Guidelines recommend a mandatory waiting period of 40 days post-PCI to reevaluate LVEF before confirming the need for ICD implantation (LVEF < 35%). Therefore, patients are at risk of sudden cardiac death (SCD). during this period.
The investigators sought to determine whether specific cardiac MRI sequences could help predict which patients would eventually recover from their LV dysfunction and therefore reduce the risk of SCD by implanting ICD earlier than recommended.
Patients presenting at our Cardiac ICU with STEMI and severe LV dysfunction (LVEF < 35%), not indicated to coronary artery bypass surgery (CABG) and free from initial cardiac arrest or severe ventricular arrhythmias, will be included. They will undergo a gadolinium-enhanced cardiac MRI during the 1st days of hospitalization with specific sequences to determine myocardial zones at risk of non-recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute STEMI within 5 last days with LVEF < 35%
- •18-80 years old
- •Admitted to the Cardiac ICU
- •Consent form
排除标准
- •CABG surgery indicated
- •Contra-indications to MRI
- •ICD or PPM in place
- •Follow-up compromised
研究组 & 干预措施
Early cardiac MRI post-STEMI
Early stages post-STEMI (within the first 5 days)
干预措施: Gadolinium-enhanced cardiac MRI (Other)
结局指标
主要结局
Mesure of ejection fraction and regional wall motion and thickening
时间窗: 40 days
Defining the area at risk with Cardiac MRI
Mesure of extracellular volume
时间窗: 40 days
Defining the area at risk with Cardiac MRI
Mesure of zones of delayed myocardial transmural enhancement and no-reflow
时间窗: 40 days
Defining the area at risk with Cardiac MRI
次要结局
- Number of ischemic cardiovascular events(40 days)
- Number of CVD events(40 days)
- Number of admission to the hospital for heart failure event(40 days)
- Number of cardiac death(40 days)