Prospective Cardiac Magnetic Resonance Imaging Study in Duchenne Muscular Dystrophy (DMD-CMP)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Late gadolinium enhancement burden on cardiac MRI
研究概览
简要总结
The purpose of this study is to describe the progression of tissular and functional myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays.
详细描述
This study is to describe the progression of tissular (late gadolinium enhancement, T1, T2, ECV assessments) and functional (segmental and global contractility, strain) myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays (troponin I, NTproBNP). Comparison between baseline and 2-years assessments will be conducted.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
DMD-CMP cohort
Minor (≥ 6 years) and major patients with genetically proven Duchenne myopathy
干预措施: Cardiac MRI (Diagnostic Test)
DMD-CMP cohort
Minor (≥ 6 years) and major patients with genetically proven Duchenne myopathy
干预措施: Blood assays (Biological)
结局指标
主要结局
Late gadolinium enhancement burden on cardiac MRI
时间窗: 2 years
次要结局
- Left ventricular ejection fraction on cardiac MRI(2 years)
- Left ventricular systolic circumferentiel strain ejection fraction on cardiac MRI(2 years)
- Global T1 on cardiac MRI(2 years)
- Left ventricular systolic longitudinal strain on cardiac MRI(2 years)
- Global T2 on cardiac MRI(2 years)
- Global extracellular volume on cardiac MRI(2 years)
- NTproBNP assay in the blood(2 years)
- Troponin I assay in the blood(2 years)
- Left ventricular systolic radial strain ejection fraction on cardiac MRI(2 years)