HealthyAUTOCARDNCT02517177
Alterations in Autonomic Cardiovascular Control Induced at Partial G Forces
A study testing Parabolic flight and Cardiovascular parameters measurements in people with Healthy, run by University Hospital, Caen at 1 site in France.
Trial summary
As a direct consequence of exposure to microgravity, astronauts experience a number of physiological changes which can lead to serious medical implications. Most immediate and significant is the headward shift of body fluids and the removal of gravitational loading from bone and muscles, resulting in progressive… Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Parabolic flight and Cardiovascular parameters measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Dec 2012
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male volunteer
- aged from 20 to 35
- affiliated to a Social Security system and, for non-French resident, holding an European Health Insurance Card (EHIC)
- who accepts to take part in the study
- who has given their written stated consent
- who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude .There will be no additional test
Who cannot join
- persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated,
- persons who take any medication or drugs influencing the autonomic cardiovascular control
Trial locations and contacts
1 site in 1 country.
About this study
As a direct consequence of exposure to microgravity, astronauts experience a number of physiological changes which can lead to serious medical implications. Most immediate and significant is the headward shift of body fluids and the removal of gravitational loading from bone and muscles, resulting in progressive changes of the cardiovascular and musculoskeletal systems. The cardiovascular systems is subject to rapid changes which has been demonstrated in studies of short term (shuttle) and long term missions to Skylab and MIR.
Our main hypothesis is that there is a linear relationship between the gravity level (0G, 0.16G, 0.38G, 1G, 1.8G) and the cardiovascular parameters (heart rate (HR), heart rate variability (HRV), blood pressure and blood pressure variability (BPV) as well the spectral analysis of HRV and BPV.
- Conditions
- Healthy
- Being tested
- Parabolic flight, Cardiovascular parameters measurements
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parabolic flightOther
Cardiovascular parameters measurementsOther
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular parameters measurements | Other | Not described Receives: Other: Parabolic flight; Other: Cardiovascular parameters measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
The heart rate (HR) and the heart rate variability (HRV) derived from the ECG
Measured: baseline
The systolic, diastolic and mean arterial blood pressure (SP, DP, MAP)
Measured: baseline
The autonomic cardiovascular control evaluated with a spectral analysis of HRV and BPV.
Measured: baseline
the blood pressure variability (BPV) derived from the continuous blood pressure recording
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startJun 2011
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517177
- Sponsor's protocol ID
- 11-008
- Acronym
- AUTOCARD
- Status last verified
- Aug 2015
- First submitted
- 23 Jul 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in Autonomic Cardiovascular Control Induced at Partial G Forces
- ClinicalTrials.gov ID
- NCT02517177
- Acronym / sponsor ID
- AUTOCARD / 11-008
- Conditions
- Healthy
- Keywords
- volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (actual)
- First posted
- 6 Aug 2015 (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.
As a direct consequence of exposure to microgravity, astronauts experience a number of physiological changes which can lead to serious medical implications. Most immediate and significant is the headward shift of body fluids and the removal of gravitational loading from bone and muscles, resulting in progressive changes of the cardiovascular and musculoskeletal systems. The cardiovascular systems is subject to rapid changes which has been demonstrated in studies of short term (shuttle) and long term missions to Skylab and MIR.
Our main hypothesis is that there is a linear relationship between the gravity level (0G, 0.16G, 0.38G, 1G, 1.8G) and the cardiovascular parameters (heart rate (HR), heart rate variability (HRV), blood pressure and blood pressure variability (BPV) as well the spectral analysis of HRV and BPV.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular parameters measurements | Other | Other: Parabolic flight, Other: Cardiovascular parameters measurements |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- healthy male volunteer
- aged from 20 to 35
- affiliated to a Social Security system and, for non-French resident, holding an European Health Insurance Card (EHIC)
- who accepts to take part in the study
- who has given their written stated consent
Key exclusion criteria (2 listed)
- persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated,
- persons who take any medication or drugs influencing the autonomic cardiovascular control
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 |
|---|---|---|
| Parabolic flight | Other | Cardiovascular parameters measurements |
| Cardiovascular parameters measurements | Other | Cardiovascular parameters measurements |
Primary outcome
The heart rate (HR) and the heart rate variability (HRV) derived from the ECG
Time frame: baseline
The systolic, diastolic and mean arterial blood pressure (SP, DP, MAP)
Time frame: baseline
The autonomic cardiovascular control evaluated with a spectral analysis of HRV and BPV.
Time frame: baseline
the blood pressure variability (BPV) derived from the continuous blood pressure recording
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parabolic flight and Cardiovascular parameters measurements in people with Healthy, 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 6 Aug 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The heart rate (HR) and the heart rate variability (HRV) derived from the ECG (time frame: baseline). The study lists 4 primary outcomes in all. 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 6 Aug 2015.