Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- All-cause Mortality
研究概览
简要总结
Dilated cardiomyopathy (DCM) is an increasingly recognized cause of morbidity and mortality with heterogenous etiologies (eg, genetic, environment) and clinical manifestations, characterized by left ventricular (LV) systolic dysfunction and LV or biventricular dilation. Previous publications reported the three-year treated mortality rates remain high at 12%-20% and a reported 5-year mortality rate up to 50%, with death resulting from ventricular arrhythmia leading to sudden cardiac death (SCD) or advanced heart failure (HF). With large fields of view and high spatial resolution, Cardiac magnetic resonance (CMR) is the reference standard for assessing cardiac mass, volume, and function. CMR also provides non noninvasive characterization of the myocardium benefiting to differential diagnosis and risk stratification.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •reduced left ventricular ejection fraction (LVEF<50%)
- •LV end-diastolic volume >2SD from normal according to normograms corrected by body surface area (BSA) and age.
排除标准
- •Any evidence indicating the presence of ischemic heart disease:
- •Coronary angiography, perfusion imaging Medical documentation that indicated the presence of ischemic heart disease An infarct pattern of late gadolinium enhancement on cardiac magnetic resonance studies and/or acute coronary syndrome or coronary revascularization during follow-up
- •Any evidence of hypertrophic cardiomyopathy, or moderate-to-severe valvular disease[18], or infiltrative disease (such as amyloidosis, sarcoidosis, Fabry disease)
- •Incessant arrhythmias
- •Inability to lie flat
- •Contraindication to cardiac magnetic resonance including severe claustrophobia, defibrillators, pacemakers, certain types of intracranial aneurysm clips, intraocular metal, and Stage IV/V chronic kidney disease
- •Diabetes mellitus with end organ damage
- •Inability to provide informed consent.
结局指标
主要结局
All-cause Mortality
时间窗: 1-10years
the incidence of all-cause death the incidence of all-cause death the incidence of all-cause death the incidence of all-cause mortality
次要结局
- A composite of SCD and aborted SCD(1-10years)
- Deterioration of HF(1-10years)
- Major adverse cardiac events(1-10years)
研究者
Minjie Lu
Vice Director of Magnetic Resonance Imaging
Chinese Academy of Medical Sciences, Fuwai Hospital