Evaluation in Healthy Volunteers of CARDIOSPACE II

Healthy Clinical Trial

— CDSII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04205032
• Other study ID #: IRCB:2019-AO1519-48
• Status: Completed
• Phase: N/A
• Start date: June 28, 2021
• Est. completion date: July 8, 2021

Study information

• Verified date: July 2021
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: July 8, 2021
• Est. primary completion date: July 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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)

Locations

Country	Name	City	State
France	CHU d'Angers, Clinical Research Center	Angers	Maine Et Loire

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Angers	Astronautic Center of China (ACC), Centre National des Etudes Spatiales - French Space Agency (CNES)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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