CARDIOSPACE Evaluation in Healthy Volunteers | NCT02704247

Studies
CARDIOSPACE Evaluation in Healthy Volunteers

NCT02704247

Sponsor

University Hospital, Angers

Status

Completed

Last Update Posted

Mar 9, 2016Estimated

Enrollment

2Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

CARDIOSPACE System

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Jun 4, 2014

First Submission Date that Met QC Criteria

Mar 4, 2016

First Posted Date

Mar 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2016

Last Update Posted Date

Mar 9, 2016Estimated

Name	Class
National Center for Spatial Study, Toulouse	UNKNOWN
Astronaut Center of China	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Label	Type	Description	Intervention Names
Testing CARDIOSPACE System	Experimental	Healthy volunteers have to test CARDIOSPACE System	Device: CARDIOSPACE System

Name	Type	Description	Arm Group Labels	Other Names
CARDIOSPACE System	Device	autonomic nervous system test tilt test ultrasound exploration at rest (heart / vessels) laser doppler + iontophoresis test sub-maximal exercise test

Measure	Description	Time Frame
Heart rate measure on ECG		1 day

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided