HealthyCARDIOSPACENCT02704247
CARDIOSPACE Evaluation in Healthy Volunteers
A study testing CARDIOSPACE System in people with Healthy, run by University Hospital, Angers at 1 site in France.
Trial summary
The aim of this porject is to test the Cardiospace system that integrates several medical devices to monitor the cardiovascular system: ECG Brachial blood pressure Continuous finger blood pressure Ultrasound Laser doppler + iontophoresis Cardiospace will be used in space station to monitor the cardiovascular system of… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CARDIOSPACE System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Apr 2014
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age : 18 to 40 years
- Size : 160 à 180
- Weight : BMI between 18 and 24
- Medical history :
- No history of cardiovascular disease
- No chronic treatment
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- No syncopal events (>2 by year)
- Physical examination
- Normal cardio-pulmonary ausculation
- Normal (DBP [60 - 90] SBP [100 - 140]
- Normal heart rate (between 50 and 80 at rest)
- Complementary examination
- Normal Electrocardiogram
- Presence of temporal acoustic window
- Capable to understand the objectives and constraints of this study
- Covered by health social insurance
- Have signed the informed consent
Who cannot join
- Pregnant woman (beta HCG by urinary test) or breastfeeding
- Refusing to sign the informed consent
- Don't understand the objectives of this study
- Minors or majors protect by the law
- Don't Benefit of social insurance
- Participation at the time of study enrolment during the present trial period in another clinical trial investigating.
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- Having reached or surpassed the annual amount of compensation allowed by clinical trials
- Receipt of any chronic and regular treatment
- Presence of sign cardiovascular diseases during the questioning
- Presence of sign cardiovascular diseases during the examination
- Presence of sign syncopals events ATCD diseases during the questioning (>2 by year)
- Absence of temporal acoustic window with the Transcranial Doppler
- Respiratory disorder, asthma
- Any troubles preventing the realization of physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of CARDIOSPACE System in Healthy Volunteers for Physiological Research in Space Environment
The aim of this porject is to test the Cardiospace system that integrates several medical devices to monitor the cardiovascular system:
- ECG
- Brachial blood pressure
- Continuous finger blood pressure
- Ultrasound
- Laser doppler + iontophoresis Cardiospace will be used in space station to monitor the cardiovascular system of astronauts for research purpuse.
- Conditions
- Healthy
- Being tested
- CARDIOSPACE System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARDIOSPACE SystemDevice
Also called Physiological tests
- autonomic nervous system test
- tilt test
- ultrasound exploration at rest (heart / vessels)
- laser doppler + iontophoresis test
- sub-maximal exercise test
| Study group | Role | What they receive |
|---|---|---|
| Testing CARDIOSPACE System | Experimental | Healthy volunteers have to test CARDIOSPACE System Receives: Device: CARDIOSPACE System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate measure on ECG
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startApr 2014
- Primary completionApr 2014
- Study completionApr 2014
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, AngersThe 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- National Center for Spatial Study, Toulouse, Astronaut Center of China
- Responsible party
- Sponsor
- Investigators
- Marc-Antoine CUSTAUD, MD, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704247
- Sponsor's protocol ID
- CHU-P 2014-01
- Acronym
- CARDIOSPACE
- Status last verified
- Jun 2014
- First submitted
- 4 Jun 2014
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of CARDIOSPACE System in Healthy Volunteers for Physiological Research in Space Environment
- ClinicalTrials.gov ID
- NCT02704247
- Acronym / sponsor ID
- CARDIOSPACE / CHU-P 2014-01
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- National Center for Spatial Study, Toulouse, Astronaut Center of China
- Study start
- Apr 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Mar 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.
The aim of this porject is to test the Cardiospace system that integrates several medical devices to monitor the cardiovascular system:
- ECG
- Brachial blood pressure
- Continuous finger blood pressure
- Ultrasound
- Laser doppler + iontophoresis Cardiospace will be used in space station to monitor the cardiovascular system of astronauts for research purpuse.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testing CARDIOSPACE System | Experimental | Device: CARDIOSPACE SystemHealthy volunteers have to test CARDIOSPACE System |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Age : 18 to 40 years
- Size : 160 à 180
- Weight : BMI between 18 and 24
- Medical history :
- Physical examination
Key exclusion criteria (14 listed)
- Pregnant woman (beta HCG by urinary test) or breastfeeding
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 |
|---|---|---|
| CARDIOSPACE SystemAlso: Physiological tests* autonomic nervous system test * tilt test * ultrasound exploration at rest (heart / vessels) * laser doppler + iontophoresis test * sub-maximal exercise test | Device | Testing CARDIOSPACE System |
Primary outcome
Heart rate measure on ECG
Time frame: 1 day
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 9 Mar 2016.
- Individual participant dataSharing planned: No
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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.
Marc-Antoine CUSTAUD, MD, PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARDIOSPACE System in people with Healthy, run by University Hospital, Angers 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 17 inclusion and 14 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 9 Mar 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?
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?
Heart rate measure on ECG (time frame: 1 day). 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 9 Mar 2016.