NCT02078076已完成不适用
IRM Cardiaque en Respiration Libre Pour Des Patients Atteints de Dystrophinopathie sévère
Institut National de la Santé Et de la Recherche Médicale, France2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Number of exams correctly acquired (feasabiliy of the exam)
研究概览
简要总结
Clinical, prospective and monocentric study aiming at assessing the feasibility of fibrosis detection and quantification (and of function assessment) during MRI without breath-holds in a population of adults and children with Duchenne myopathy.
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dystophinopathy (Duchenne or severe Becker)
- •with social insurance
- •informed consent
排除标准
- •impossibility to undergo an MRI (pacemaker, ....)
结局指标
主要结局
Number of exams correctly acquired (feasabiliy of the exam)
时间窗: after the last inclusion
Was it possible to acquire the whole examination for every patient ?
Number of exams allowing a qualitative assessment of images by the physician
时间窗: after the last MRI exam
The image quality allows a qualitative diagnosis ?
Number of exams allowing a quantitative assessment of the diagnosis
时间窗: after the last MRI examination
Did the image quality allow a quantitative assessment of the diagnosis ?
次要结局
- Number of anatomic cardiac segments with significant fibrosis according to the assessment methods (conventional LGE, qualitative detection with GRICS, and quantiative measure with GRICS)(after the last inclusion)
- Number of cardiac segments with fibrosis and/or regional dysfunction(after the last inclusion)
研究者
研究点 (2)
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