Effects of Microgravity on Central Aortic Pressure During Parabolic Flights

Healthy Volunteers Clinical Trial

— CapFlight  

Official title:

Effects of Microgravity on Central Aortic Pressure During Parabolic Flights

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02789072
• Other study ID #: 2015-A01259-40
• Status: Recruiting
• Phase: N/A
• First received: April 21, 2016
• Last updated: May 27, 2016
• Start date: September 2015
• Est. completion date: September 2018

Study information

• Verified date: May 2016
• Source: University Hospital, Caen
• Contact: Pierre DP Denise, PhD
• Phone: 02.31.06.81.32
• Email: pierre.denise[@]unicaen.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
France	Caen CHU	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Novespace

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	central aortic pressure	effect of microgravity on central aortic blood pressure (measured in mmHg).	baseline	No