Effects of Microgravity on Central Aortic Pressure During Parabolic Flights (CapFlight)

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.

Study Overview

• Status: Unknown
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: central aortic pressure (measured in mmHg).

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14000
    • Recruiting
    • Caen CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
central aortic pressure	effect of microgravity on central aortic blood pressure (measured in mmHg).	baseline

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: Novespace
• Investigators: Principal Investigator: Pierre DP Denise, PhD, CHU Caen

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: April 21, 2016
• First Submitted That Met QC Criteria: May 27, 2016
• First Posted (Estimate): June 2, 2016

Study Record Updates

• Last Update Posted (Estimate): June 2, 2016
• Last Update Submitted That Met QC Criteria: May 27, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 2015-A01259-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO