Evaluation in Healthy Volunteers of CARDIOSPACE II

NCT04205032 | Completed

• 1 other identifier: IRCB:2019-AO1519-48
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

CARDIOSPACE II

EXPERIMENTAL

Test of the different devices integrated in cardiospace II.

Device: Test of the different devices integrated in cardiospace II

Interventions

Test of the different devices integrated in cardiospace II 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)

CARDIOSPACE II

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

CHU d'Angers, Clinical Research Center

Angers, Maine Et Loire, 49000, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 19, 2019
• Study Start: June 28, 2021
• Primary Completion: July 2, 2021
• Study Completion: July 8, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

FR (1)