Effects of Microgravity on Central Aortic Pressure During Parabolic Flights

NCT ID: NCT02789072

Last Updated: 2016-06-02

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-09-30

Brief Summary

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Cardiovascular events remain the main cause of death of the industrialized world (Global status report on noncommunicable diseases 2010. Geneva, World Health Organization, 2011). Arterial hypertension, hyperlipoproteinemia, smoking, diabetes and family history represent the main cardiovascular risk factors. Arteriosclerosis leads to coronary heart disease, cerebrovascular insufficiency and peripheral vascular diseases that reflect in myocardial infarction and stroke.

The main objective of this experiment is to investigate the differential effect of microgravity on central aortic blood pressure.

The main criterion is the central aortic pressure (measured in mmHg). The hypothesis is that microgravity leads to an increased central aortic pressure.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Microgravity

effect of microgravity on central aortic blood pressure.

Group Type OTHER

central aortic pressure (measured in mmHg).

Intervention Type OTHER

Blood pressure will only be measured during the 0g (microgravity) phase. Seven 5 ml blood sample will be drawn in the aircraft: before the first parabola (1) and after each block of 5 parabola (6).

On ground after flight, a 9th 5 ml blood sample will be drawn and then the mobil-o-graph, the SOMNOtouch NIBP and the intravenous cannula will be removed.

Interventions

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central aortic pressure (measured in mmHg).

Blood pressure will only be measured during the 0g (microgravity) phase. Seven 5 ml blood sample will be drawn in the aircraft: before the first parabola (1) and after each block of 5 parabola (6).

On ground after flight, a 9th 5 ml blood sample will be drawn and then the mobil-o-graph, the SOMNOtouch NIBP and the intravenous cannula will be removed.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers (men or women)
* Aged from 18 to 65
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who have given their written stated consent
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Subjects will be staff member of the team or of other teams participating in the parabolic flight campaign.

Exclusion Criteria

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Treated or non-treated arterial hypertension
* History of cardiovascular disease
* Pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novespace

INDUSTRY

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre DP Denise, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU CAEN

Locations

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Caen CHU

Caen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre DP Denise, PhD

Role: CONTACT

02.31.06.81.32 ext. +33

Cathy GC Gaillard

Role: CONTACT

02 31 06 53 49 ext. +33

Other Identifiers

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2015-A01259-40

Identifier Type: -

Identifier Source: org_study_id

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