Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy: The PREDICT-DCM Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Primary Combined Endpoint
研究概览
简要总结
PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder implantation.
详细描述
Prophylactic ICD implantation was recently found to be non-beneficial over usual clinical care in non-ischemic systolic heart failure (LVEF≤35%) and 60-70% percent of SCD cases even occur in individuals with LEVF>35%. A growing evidence, that emphasizes the urgent need to improve the prediction of sudden cardiac death (SCD) in dilated cardiomyopathy (DCM).
CMR provides unique information on myocardial mechanics, fibrotic burden, inflammation and microvascular dysfunction, thereby allowing to quantify key substrates for myocardial arrhythmogenic potential.
PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder implantation.
Acquired candidate predictors are among others:
- Global and regional T1/T2
- T1/T2 inhomogeneity
- Extracellular volume fraction
- Microvascular dysfunction
- LA function and filling fraction
- Global and regional circumferential, radial or longitudinal myocardial strain
- Biomarkers
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dilated Cardiomyopathy
- •ICD Indication
- •age ≥ 18 years
- •signed informed consent
排除标准
- •severe claustrophobia
- •rest dyspnea
- •tachycardia or severe arrhythmia
- •intolerance to gadolinium-based contrast agent
结局指标
主要结局
Primary Combined Endpoint
时间窗: 18 months
Sudden Cardiac Death OR sustained VT OR non-sustained, long run VT
次要结局
- Mortality(18 months)
研究者
Marco Ochs
Dr. med. Marco Ochs
University Hospital Heidelberg