CARDIOSPACE Evaluation in Healthy Volunteers

Healthy Clinical Trial

— CARDIOSPACE  

Official title:

Evaluation of CARDIOSPACE System in Healthy Volunteers for Physiological Research in Space Environment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02704247
• Other study ID #: CHU-P 2014-01
• Status: Completed
• Phase: N/A
• First received: June 4, 2014
• Last updated: March 4, 2016
• Start date: April 2014
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this porject is to test the Cardiospace system that integrates several medical devices to monitor the cardiovascular system:

• ECG

• Brachial blood pressure

• Continuous finger blood pressure

• Ultrasound

• Laser doppler + iontophoresis Cardiospace will be used in space station to monitor the cardiovascular system of astronauts for research purpuse.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age : 18 to 40 years

• Size : 160 à 180

• Weight : BMI between 18 and 24

• Medical history :

• No history of cardiovascular disease

• No chronic treatment

• No syncopal events (>2 by year)

• Physical examination

• Normal cardio-pulmonary ausculation

• Normal (DBP [60 - 90] SBP [100 - 140]

• Normal heart rate (between 50 and 80 at rest)

• Complementary examination

• Normal Electrocardiogram

• Presence of temporal acoustic window

• Capable to understand the objectives and constraints of this study

• Covered by health social insurance

• Have signed the informed consent

Exclusion Criteria:

• Pregnant woman (beta HCG by urinary test) or breastfeeding

• Refusing to sign the informed consent

• Don't understand the objectives of this study

• Minors or majors protect by the law

• Don't Benefit of social insurance

• Participation at the time of study enrolment during the present trial period in another clinical trial investigating.

• Having reached or surpassed the annual amount of compensation allowed by clinical trials

• Receipt of any chronic and regular treatment

• Presence of sign cardiovascular diseases during the questioning

• Presence of sign cardiovascular diseases during the examination

• Presence of sign syncopals events ATCD diseases during the questioning (>2 by year)

• Absence of temporal acoustic window with the Transcranial Doppler

• Respiratory disorder, asthma

• Any troubles preventing the realization of physical activity

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• CARDIOSPACE System
autonomic nervous system test tilt test ultrasound exploration at rest (heart / vessels) laser doppler + iontophoresis test sub-maximal exercise test

Locations

Country	Name	City	State
France	Centre de Recherche Clinique, CHU d'Angers	Angers

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Angers	Astronaut Center of China, National Center for Spatial Study, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate measure on ECG		1 day	No