NCT02704247已完成不适用
Evaluation of CARDIOSPACE System in Healthy Volunteers for Physiological Research in Space Environment
University Hospital, Angers2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2014年4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
- 2
- 试验地点
- 2
- 主要终点
- Heart rate measure on ECG
研究概览
简要总结
The aim of this porject is to test the Cardiospace system that integrates several medical devices to monitor the cardiovascular system:
- ECG
- Brachial blood pressure
- Continuous finger blood pressure
- Ultrasound
- Laser doppler + iontophoresis Cardiospace will be used in space station to monitor the cardiovascular system of astronauts for research purpuse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age : 18 to 40 years
- •Size : 160 à 180
- •Weight : BMI between 18 and 24
- •Medical history :
- •No history of cardiovascular disease
- •No chronic treatment
- •No syncopal events (>2 by year)
- •Physical examination
- •Normal cardio-pulmonary ausculation
- •Normal (DBP [60 - 90] SBP [100 - 140]
- •Normal heart rate (between 50 and 80 at rest)
- •Complementary examination
- •Normal Electrocardiogram
- •Presence of temporal acoustic window
- •Capable to understand the objectives and constraints of this study
- •Covered by health social insurance
- •Have signed the informed consent
排除标准
- •Pregnant woman (beta HCG by urinary test) or breastfeeding
- •Refusing to sign the informed consent
- •Don't understand the objectives of this study
- •Minors or majors protect by the law
- •Don't Benefit of social insurance
- •Participation at the time of study enrolment during the present trial period in another clinical trial investigating.
- •Having reached or surpassed the annual amount of compensation allowed by clinical trials
- •Receipt of any chronic and regular treatment
- •Presence of sign cardiovascular diseases during the questioning
- •Presence of sign cardiovascular diseases during the examination
- •Presence of sign syncopals events ATCD diseases during the questioning (>2 by year)
- •Absence of temporal acoustic window with the Transcranial Doppler
- •Respiratory disorder, asthma
- •Any troubles preventing the realization of physical activity
结局指标
主要结局
Heart rate measure on ECG
时间窗: 1 day
次要结局
未报告次要终点
研究者
研究点 (2)
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