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CARDIOSPACE Evaluation in Healthy Volunteers (CARDIOSPACE)

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ClinicalTrials.gov Identifier: NCT02704247
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : March 9, 2016
Sponsor:
Collaborators:
National Center for Spatial Study, Toulouse
Astronaut Center of China
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Healthy Device: CARDIOSPACE System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of CARDIOSPACE System in Healthy Volunteers for Physiological Research in Space Environment
Study Start Date : April 2014
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
Experimental: Testing CARDIOSPACE System
Healthy volunteers have to test CARDIOSPACE System
Device: CARDIOSPACE System
  • autonomic nervous system test
  • tilt test
  • ultrasound exploration at rest (heart / vessels)
  • laser doppler + iontophoresis test
  • sub-maximal exercise test
Other Name: Physiological tests




Primary Outcome Measures :
  1. Heart rate measure on ECG [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704247


Locations
France
Centre de Recherche Clinique, CHU d'Angers
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
National Center for Spatial Study, Toulouse
Astronaut Center of China
Investigators
Principal Investigator: Marc-Antoine CUSTAUD, MD, PhD University Hospital, Angers

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02704247     History of Changes
Other Study ID Numbers: CHU-P 2014-01
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: June 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No