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CompletedNCT02704247CARDIOSPACEUpdated Mar 9, 2016

CARDIOSPACE Evaluation in Healthy Volunteers

An interventional study of CARDIOSPACE System in Healthy, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-09.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Testing CARDIOSPACE System

    Healthy volunteers have to test CARDIOSPACE System

    Device: CARDIOSPACE System

Interventions

  • DeviceCARDIOSPACE System

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

    Also known as: Physiological tests

06

What researchers measure

Primary outcomes

  1. Heart rate measure on ECG

    Time frame: 1 day

07

Study locations

1 site
  • Centre de Recherche Clinique, CHU d'Angers
    Angers, 49933, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02704247
Lead sponsor
University Hospital, Angers
Collaborators
National Center for Spatial Study, Toulouse, Astronaut Center of China
Responsible party
Sponsor
First posted
Mar 9, 2016
Start date
Apr 2014
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Mar 9, 2016

Study contacts

Marc-Antoine CUSTAUD, MD, PhD
principal investigator · University Hospital, Angers

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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