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CARDIOSPACE Evaluation in Healthy Volunteers

U

University Hospital, Angers

Status

Completed

Conditions

Healthy

Treatments

Device: CARDIOSPACE System

Study type

Interventional

Funder types

Other

Identifiers

NCT02704247
CHU-P 2014-01

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 1 patient group

Testing CARDIOSPACE System
Experimental group
Description:
Healthy volunteers have to test CARDIOSPACE System
Treatment:
Device: CARDIOSPACE System

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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