NCT00484549已完成不适用
National, Multicenter, Prospective Study of Screening of Fabry Disease in a Population of Men Over 28 Days Old and Less Than 55 Years, Hospitalized for an Ischemic Stroke.
University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 889 人开始时间: 2007年3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
- 889
- 试验地点
- 2
- 主要终点
- Fabry disease's screening (Positive microdosage confirmed by a macrodosage)
研究概览
简要总结
Fabry disease is a genetic disease due to an enzymatic deficit. A screening of this disease allows patients to benefit from an enzyme replacement therapy and prevent the occurrence of life threatening manifestations such as an ischemic stroke.
The purpose of the study is to determinate the prevalence of Fabry disease in a population of male patients hospitalized for an ischemic stroke.
This study, with a screening of Fabry disease, allows the patients to make a precise diagnosis of their ischemic stroke and to facilitate the screening of the other members at the facility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 28 Days 至 55 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Hospitalized ischemic stroke
- •Written and signed informed consent from patient or legal representative
排除标准
- •Patients belonging to a family which has a Fabry disease's diagnosis confirmed
结局指标
主要结局
Fabry disease's screening (Positive microdosage confirmed by a macrodosage)
时间窗: Positive microdosage confirmed by a macrodosage
次要结局
- Describe and compare the characteristics of patients affected by Fabry disease and patients who are not affected Identify clinical and neuroradiological predictive elements of Fabry disease(patients affected by Fabry disease)
研究者
研究点 (2)
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