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Completed

NCT Number: NCT02704247

CARDIOSPACE Evaluation in Healthy Volunteers

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Recherche Clinique, CHU d'Angers

Angers, 49933, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CARDIOSPACE System

Device
  • autonomic nervous system test
  • tilt test
  • ultrasound exploration at rest (heart / vessels)
  • laser doppler + iontophoresis test
  • sub-maximal exercise test

Other names: Physiological tests

Primary outcomes

  1. Heart rate measure on ECG

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Collaborators

  • Astronaut Center of China
  • National Center for Spatial Study, Toulouse

Registry information

Official study title

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

Acronym: CARDIOSPACE

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 9, 2016
Registry last updated
Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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