Evaluation in Healthy Volunteers of CARDIOSPACE II (CDSII)

Evaluation in Healthy Volunteers of CARDIOSPACE II for Physiological Studies in Space

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Test of the different devices integrated in cardiospace II

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Maine Et Loire
    • Angers, Maine Et Loire, France, 49000
      • CHU d'Angers, Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CARDIOSPACE II; Test of the different devices integrated in cardiospace II.	Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of the ECG signal given by CARDIOSPACE II: scale	ECG signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise	Through study completion, an average of 6 months
Quality of the vascular Doppler signal: scale	Doppler signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise	Through study completion, an average of 6 months
Quality of the laser doppler signal: scale	Laser Doppler signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise	Through study completion, an average of 6 months
Quality of the ultrasound images: scale	Ultrasound images will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable image and 5 is a very clear image	Through study completion, an average of 6 months
Quality of the blood pressure wave: scale	Blood pressure wave signal will be estimated by by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise	Through study completion, an average of 6 months
Quality of the ambulatory measurements (ECG / SAO2)	ECG and SaO2 ambulatory measurements will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Collaborators: Centre National des Etudes Spatiales - French Space Agency (CNES); Astronautic Center of China (ACC)

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Actual): July 2, 2021
• Study Completion (Actual): July 8, 2021

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: IRCB:2019-AO1519-48

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No