CARDIOSPACE Evaluation in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of CARDIOSPACE System in Healthy Volunteers for Physiological Research in Space Environment

Conditions
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Healthy

Intervention / Treatment
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* Device: CARDIOSPACE System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testing CARDIOSPACE System<br>Healthy volunteers have to test CARDIOSPACE System | Device: CARDIOSPACE System<br>* autonomic nervous system test tilt test ultrasound exploration at rest (heart / vessels) laser doppler + iontophoresis test sub-maximal exercise test<br>* Other names: Physiological tests;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate measure on ECG |  | 1 day |