Evaluation in Healthy Volunteers of CARDIOSPACE II (CDSII)

University Hospital, Angers

Status

Completed

Conditions

Healthy

Treatments

Device: Test of the different devices integrated in cardiospace II

Study type

Interventional

Funder types

Other

Identifiers

NCT04205032

IRCB:2019-AO1519-48

Details and patient eligibility

About

The aim of this project is to test the CARDIOSPACE II system that integrates several medical devices. This system is dedicated to physiological studies in space environment.

Electrocardiogram
Vascular doppler
Laser doppler with iontophoresis
Continuous blood pressure recording at the finger level
Brachial blood pressure
Ultrasound
Ambulatory Electrocardiogram and SAO2 (arterial oxygen saturation) recorder

Enrollment

4 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Height between 160 et 180 cm
Body mass index between 18 et 24
Normal blood pressure, heart rate and cardio-pulmonary auscultation at rest
Normal electrocardiogram
Possibility to perform transcranial doppler
Able to understand aims and constraints of this study
National health insurance
Signature of the informed consent form

Exclusion criteria

Pregnant woman (Beta HCG - human chorionic gonadotropin - with urinary test) or breastfeeding
Participating at the time to another clinical trial investigating
Reached or surpassed the annual amount of financial compensation allowed by clinical trials (according to French regulation)
Taking any chronic treatment
Any sign of cardiovascular or respiration disease
Any sign of syncopal events by questioning (>2 events per year)
Contraindication to perform physical activity