CapFlight: Effects of Microgravity on Central Aortic Pressure During Parabolic Flights

Sponsor

University Hospital, Caen (Other)

Overall Status

Unknown status

CT.gov ID

NCT02789072

Collaborator

Novespace (Industry)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Other: central aortic pressure (measured in mmHg).	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Effects of Microgravity on Central Aortic Pressure During Parabolic Flights

Study Start Date :

Sep 1, 2015

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Sep 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Microgravity effect of microgravity on central aortic blood pressure.	Other: 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.

Arm

Intervention/Treatment

Other: Microgravity

effect of microgravity on central aortic blood pressure.

Other: 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.

Outcome Measures

Primary Outcome Measures

central aortic pressure [baseline]
effect of microgravity on central aortic blood pressure (measured in mmHg).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Caen CHU	Caen		France	14000

Sponsors and Collaborators

University Hospital, Caen
Novespace

Investigators

Principal Investigator: Pierre DP Denise, PhD, CHU Caen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT02789072

Other Study ID Numbers:

2015-A01259-40

First Posted:

Jun 2, 2016

Last Update Posted:

Jun 2, 2016

Last Verified:

May 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Jun 2, 2016