CARDIOSPACE Evaluation in Healthy Volunteers

NCT ID: NCT02704247

Last Updated: 2016-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Testing CARDIOSPACE System

Healthy volunteers have to test CARDIOSPACE System

Group Type EXPERIMENTAL

CARDIOSPACE System

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CARDIOSPACE System

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Physiological tests

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Spatial Study, Toulouse

UNKNOWN

Sponsor Role collaborator

Astronaut Center of China

UNKNOWN

Sponsor Role collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marc-Antoine CUSTAUD, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre de Recherche Clinique, CHU d'Angers

Angers, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHU-P 2014-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.