Multicenter randomiSed Trial on MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,812
- 试验地点
- 2
- 主要终点
- Occurrence of Sudden Cardiac Death (SCD) during the follow-up period
研究概览
简要总结
Implantable cardioverter-defibrillators (ICD) are currently recommended for the primary prevention of sudden cardiac death (SCD) in patients with a remote (>6 weeks) myocardial infarction (MI) and a low (≤35%) left ventricular ejection fraction (LVEF).
Ventricular tachycardia (VT) and/or ventricular fibrillation (VF), which are responsible for most SCDs, result from the presence of surviving myocytes embedded within fibrotic MI-scar. The presence of these surviving myocytes, as well as their specific arrhythmic characteristics, is not captured by LVEF. Hence, the use of LVEF as a unique risk-stratifier of SCD results in a low proportion (17 to 31%) of appropriate ICD device therapy at 2 years. Consequently, most patients with a prophylactic ICD do not present VT/VF requiring ICD therapy prior to their first-ICD battery depletion. Thus, many patients are exposed to ICD complications, such as inappropriate shocks, without deriving any health benefit. Therefore, the current implantation strategy of prophylactic ICDs, based on LVEF only, needs to be improved in post-MI patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age > 18 years;
- •Patients with a LVEF≤35% assessed at least after a 40 to 90 days period (depending on the presence of coronary revascularization) following an index myocardial infarction;
- •Left ventricular systolic impairment as defined by LVEF≤35% by any current standard technique (echocardiogram, multiple gated acquisition scan, or MRI) within 2 months;
- •Able and willing to comply with all pre-, post- and follow-up testing, and requirements;
- •Use of maximum tolerated doses of ACE inhibitors (or Angiotensin II Receptor Blockers if intolerant of ACE) and Beta Blockers and MRA as per ESC guidelines;
- •Person affiliated to or beneficiary of a social security plan
- •Person informed about study organization and having signed the informed consent
排除标准
- •History of cardiac arrest or sustained VT or VF unless within 48 hours of an acute myocardial infarction;
- •Standard contraindications for cardiac LGE-MRI;
- •Hypersensitivity to gadolinium-based contrast agent;
- •Currently implanted permanent pacemaker and/or ICD;
- •Patient refusal of ICD/ILR implantation;
- •Currently implanted permanent pacemaker and/or ICD;
- •Clinical indication for or Cardiac Resynchronization Therapy (CRT);
- •Severe renal insufficiency defined by a glomerular filtration rate (GFR) < 30 mL/min/1.73m²;
- •Recent PTCA (within 30 days) or CABG (within 90 days);
- •Baseline NYHA functional class IV;
- •Contraindication for ICD implantation according to current guidelines;
- •Woman of childbearing age without effective contraception;
- •Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the French Public Health Code.
研究组 & 干预措施
Implantable Loop Recorder
Patients identified at very low-risk of VT/VF randomized to be implanted with an ILR (experimental strategy). Following randomization, these patients will be followed using remote ILR monitoring.
干预措施: MRI screening (Device)
Implantable Cardioverter Defibrillator
Patients identified at very low-risk of VT/VF randomized to be implanted with an ICD (reference strategy), which corresponds to the currently recommended treatment in post-MI patients with a LVEF ≤35% (European Society of Cardiology guidelines 2015) (Zeppenfeld et al., 2022).
干预措施: Implantable Cardioverter Defibrillator (Device)
Implantable Loop Recorder
Patients identified at very low-risk of VT/VF randomized to be implanted with an ILR (experimental strategy). Following randomization, these patients will be followed using remote ILR monitoring.
干预措施: Implantable Loop Recorder (Device)
Implantable Cardioverter Defibrillator
Patients identified at very low-risk of VT/VF randomized to be implanted with an ICD (reference strategy), which corresponds to the currently recommended treatment in post-MI patients with a LVEF ≤35% (European Society of Cardiology guidelines 2015) (Zeppenfeld et al., 2022).
干预措施: MRI screening (Device)
结局指标
主要结局
Occurrence of Sudden Cardiac Death (SCD) during the follow-up period
时间窗: 72 months
Occurrence of SCD during the follow-up period, as defined by the World Health Organization in 10-ICD: death occurring within 24 hours from onset of symptoms.
次要结局
- Total number (per patient) of sustained VT episodes treated by the ICD or recorded by the ILR during the follow-up period(72 months)
- Total number of deaths during the follow-up period(72 months)
- Total number of SCD due to ventricular arrhythmia during the follow-up period(72 months)
- Duration of hospitalizations due to cardiovascular causes during the follow-up period(72 months)
- Quality of life assessed by the scoring obtained from EuroQol questionnaires (EQ-5D-5L) during the follow-up period(72 months)
- Measurements of the estimated costs(72 months)
- Dice scores of the accuracy of fully automated segmentation of the left ventricle and scar(36 months)
- Contour distance metrics of the accuracy of fully automated segmentation of the left ventricle and scar(36 months)
- Total number of deaths from cardiovascular cause during the follow-up period(72 months)
- Total number (per patient) of VF episodes treated by the ICD or recorded by the ILR during the follow-up period(72 months)
- Total number of hospitalizations due to cardiovascular causes during the follow-up period(72 months)
- Dice scores of the segmentation of the left ventricle and scar obtained from new MR sequences(36 months)
- Total number of hospitalizations from any cause during the follow-up period(72 months)
- Duration of hospitalizations from any cause during the follow-up period(72 months)
- Contour distance metrics of the segmentation of the left ventricle and scar obtained from new MR sequences(36 months)
研究者
Christian DE CHILLOU
Coordinating Investigator
Central Hospital, Nancy, France