Evaluation in Healthy Volunteers of CARDIOSPACE II

NCT ID: NCT04205032

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-28

Study Completion Date

2021-07-08

Brief Summary

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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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CARDIOSPACE II

Test of the different devices integrated in cardiospace II.

Group Type EXPERIMENTAL

Test of the different devices integrated in cardiospace II

Intervention Type DEVICE

The different devices included in CARDIOSPACE II will be tested

* Electrocardiogram
* Vascular Doppler
* LaserDoppler and iontophoresis
* Brachial blood pressure
* Continuous blood pressure recorded at the finger level
* Ultrasound
* Ambulatory Electrocardiogram / SAO2 (arterial oxygen saturation)

Interventions

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Test of the different devices integrated in cardiospace II

The different devices included in CARDIOSPACE II will be tested

* Electrocardiogram
* Vascular Doppler
* LaserDoppler and iontophoresis
* Brachial blood pressure
* Continuous blood pressure recorded at the finger level
* Ultrasound
* Ambulatory Electrocardiogram / SAO2 (arterial oxygen saturation)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre National des Etudes Spatiales - French Space Agency (CNES)

UNKNOWN

Sponsor Role collaborator

Astronautic Center of China (ACC)

UNKNOWN

Sponsor Role collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU d'Angers, Clinical Research Center

Angers, Maine Et Loire, France

Site Status

Countries

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France

Other Identifiers

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IRCB:2019-AO1519-48

Identifier Type: -

Identifier Source: org_study_id

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