CARDIOSPACE Evaluation in Healthy Volunteers

NCT02704247 | Completed DMC

• 1 other identifier: CHU-P 2014-01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Heart rate measure on ECG

  1 day

Study Arms (1)

Testing CARDIOSPACE System

EXPERIMENTAL

Healthy volunteers have to test CARDIOSPACE System

Device: CARDIOSPACE System

Interventions

CARDIOSPACE System DEVICE

* autonomic nervous system test * tilt test * ultrasound exploration at rest (heart / vessels) * laser doppler + iontophoresis test * sub-maximal exercise test

Also known as: Physiological tests

Testing CARDIOSPACE System

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead
• National Center for Spatial Study, Toulouse: collaborator
• Astronaut Center of China: collaborator

Study Sites (1)

Centre de Recherche Clinique, CHU d'Angers

Angers, 49933, France

Location

Study Officials

• Marc-Antoine CUSTAUD, MD, PhD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 4, 2014
• First Posted: March 9, 2016
• Study Start: April 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 9, 2016

Record last verified: 2014-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)