CARDIOSPACE Evaluation in Healthy Volunteers (CARDIOSPACE)

March 4, 2016 updated by: University Hospital, Angers

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Centre de Recherche Clinique, CHU d'Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Physiological tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Heart rate measure on ECG
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Collaborators

National Center for Spatial Study, Toulouse
Astronaut Center of China

Investigators

  • Principal Investigator: Marc-Antoine CUSTAUD, MD, PhD, University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimate)

March 9, 2016

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 4, 2016

Last Verified

June 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • CHU-P 2014-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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