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CARDIOSPACE Evaluation in Healthy Volunteers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02704247
Acronym
CARDIOSPACE
Enrollment
2
Registered
2016-03-09
Start date
2014-04-30
Completion date
2014-04-30
Last updated
2016-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DEVICECARDIOSPACE System

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

Sponsors

National Center for Spatial Study, Toulouse
CollaboratorUNKNOWN
Astronaut Center of China
CollaboratorUNKNOWN
University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
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

* 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

Design outcomes

Primary

MeasureTime frame
Heart rate measure on ECG1 day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026