Healthy VolunteersCapFlightNCT02789072
Effects of Microgravity on Central Aortic Pressure During Parabolic Flights
A study testing central aortic pressure (measured in mmHg). in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- central aortic pressure (measured in mmHg).
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- central aortic pressure (measured in mmHg).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Microgravity | Other | effect of microgravity on central aortic blood pressure. Receives: Other: central aortic pressure (measured in mmHg). |
What is being measured
The primary outcome is the main question the study is designed to answer.
central aortic pressure
effect of microgravity on central aortic blood pressure (measured in mmHg).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Novespace
- Responsible party
- Sponsor
- Investigators
- Pierre DP Denise, PhD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789072
- Sponsor's protocol ID
- 2015-A01259-40
- Acronym
- CapFlight
- Status last verified
- May 2016
- First submitted
- 21 Apr 2016
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Microgravity on Central Aortic Pressure During Parabolic Flights
- ClinicalTrials.gov ID
- NCT02789072
- Acronym / sponsor ID
- CapFlight / 2015-A01259-40
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Novespace
- Study start
- Sep 2015
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microgravity | Other | Other: central aortic pressure (measured in mmHg).effect of microgravity on central aortic blood pressure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Microgravity |
Primary outcome
central aortic pressure
Time frame: baseline
effect of microgravity on central aortic blood pressure (measured in mmHg).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre DP Denise, PhD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing central aortic pressure (measured in mmHg). in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre DP Denise, PhD (02.31.06.81.32 ext. +33, pierre.denise@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central aortic pressure (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2016.