Effects of Microgravity on Central Aortic Pressure During Parabolic Flights

NCT02789072 | Unknown

• 1 other identifier: 2015-A01259-40
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• central aortic pressure

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

  baseline

Study Arms (1)

Microgravity

OTHER

effect of microgravity on central aortic blood pressure.

Other: central aortic pressure (measured in mmHg).

Interventions

central aortic pressure (measured in mmHg). 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.

Microgravity

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Treated or non-treated arterial hypertension
• History of cardiovascular disease
• Pregnant women

Sponsors & Collaborators

• University Hospital, Caen: lead
• Novespace: collaborator

Study Sites (1)

Caen CHU

Caen, 14000, France

RECRUITING

Study Officials

• Pierre DP Denise, PhD

  CHU CAEN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre DP Denise, PhD

CONTACT

02.31.06.81.32; pierre.denise@unicaen.fr

Cathy GC Gaillard

CONTACT

02 31 06 53 49; gaillard-c@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: June 2, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: June 2, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)