HealthyCDSIINCT04205032
Evaluation in Healthy Volunteers of CARDIOSPACE II
A study testing Test of the different devices integrated in cardiospace II in people with Healthy, run by University Hospital, Angers at 1 site in France.
Trial summary
The aim of this project is to test the CARDIOSPACE II system that integrates several medical devices. This system is dedicated to physiological studies in space environment. Electrocardiogram Vascular doppler Laser doppler with iontophoresis Continuous blood pressure recording at the finger level Brachial blood… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Test of the different devices integrated in cardiospace II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2021to 8 Jul 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Height between 160 et 180 cm
- Body mass index between 18 et 24
- Normal blood pressure, heart rate and cardio-pulmonary auscultation at rest
- Normal electrocardiogram
- Possibility to perform transcranial doppler
- Able to understand aims and constraints of this study
- National health insurance
- Signature of the informed consent form
Who cannot join
- Pregnant woman (Beta HCG - human chorionic gonadotropin - with urinary test) or breastfeeding
- Participating at the time to another clinical trial investigating
- Reached or surpassed the annual amount of financial compensation allowed by clinical trials (according to French regulation)
- Taking any chronic treatment
- Any sign of cardiovascular or respiration disease
- Any sign of syncopal events by questioning (>2 events per year)
- Contraindication to perform physical activity
Trial locations and contacts
1 site in 1 country.
France1 site
CHU d'Angers, Clinical Research Center
Angers, Maine Et Loire, 49000
About this study
Official title: Evaluation in Healthy Volunteers of CARDIOSPACE II for Physiological Studies in Space
The aim of this project is to test the CARDIOSPACE II system that integrates several medical devices. This system is dedicated to physiological studies in space environment.
- Electrocardiogram
- Vascular doppler
- Laser doppler with iontophoresis
- Continuous blood pressure recording at the finger level
- Brachial blood pressure
- Ultrasound
- Ambulatory Electrocardiogram and SAO2 (arterial oxygen saturation) recorder
- Conditions
- Healthy
- Being tested
- Test of the different devices integrated in cardiospace II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test of the different devices integrated in cardiospace IIDevice
The different devices included in CARDIOSPACE II will be tested
- Electrocardiogram
- Vascular Doppler
- LaserDoppler and iontophoresis
- Brachial blood pressure
- Continuous blood pressure recorded at the finger level
- Ultrasound
- Ambulatory Electrocardiogram / SAO2 (arterial oxygen saturation)
| Study group | Role | What they receive |
|---|---|---|
| CARDIOSPACE II | Experimental | Test of the different devices integrated in cardiospace II. Receives: Device: Test of the different devices integrated in cardiospace II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of the ECG signal given by CARDIOSPACE II: scale
ECG signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise
Measured: Through study completion, an average of 6 months
Quality of the vascular Doppler signal: scale
Doppler signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise
Measured: Through study completion, an average of 6 months
Quality of the laser doppler signal: scale
Laser Doppler signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise
Measured: Through study completion, an average of 6 months
Quality of the ultrasound images: scale
Ultrasound images will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable image and 5 is a very clear image
Measured: Through study completion, an average of 6 months
Quality of the blood pressure wave: scale
Blood pressure wave signal will be estimated by by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise
Measured: Through study completion, an average of 6 months
Quality of the ambulatory measurements (ECG / SAO2)
ECG and SaO2 ambulatory measurements will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start28 Jun 2021
- Primary completion2 Jul 2021
- Study completion8 Jul 2021
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Centre National des Etudes Spatiales - French Space Agency (CNES), Astronautic Center of China (ACC)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205032
- Sponsor's protocol ID
- IRCB:2019-AO1519-48
- Acronym
- CDSII
- Status last verified
- Jul 2021
- First submitted
- 11 Dec 2019
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation in Healthy Volunteers of CARDIOSPACE II for Physiological Studies in Space
- ClinicalTrials.gov ID
- NCT04205032
- Acronym / sponsor ID
- CDSII / IRCB:2019-AO1519-48
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Centre National des Etudes Spatiales - French Space Agency (CNES), Astronautic Center of China (ACC)
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 19 Dec 2019 (actual)
- 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 project is to test the CARDIOSPACE II system that integrates several medical devices. This system is dedicated to physiological studies in space environment.
- Electrocardiogram
- Vascular doppler
- Laser doppler with iontophoresis
- Continuous blood pressure recording at the finger level
- Brachial blood pressure
- Ultrasound
- Ambulatory Electrocardiogram and SAO2 (arterial oxygen saturation) recorder
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CARDIOSPACE II | Experimental | Device: Test of the different devices integrated in cardiospace IITest of the different devices integrated in cardiospace II. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Height between 160 et 180 cm
- Body mass index between 18 et 24
- Normal blood pressure, heart rate and cardio-pulmonary auscultation at rest
- Normal electrocardiogram
- Possibility to perform transcranial doppler
Key exclusion criteria (7 listed)
- Pregnant woman (Beta HCG - human chorionic gonadotropin - with urinary test) or breastfeeding
- Participating at the time to another clinical trial investigating
- Reached or surpassed the annual amount of financial compensation allowed by clinical trials (according to French regulation)
- Taking any chronic treatment
- Any sign of cardiovascular or respiration disease
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 |
|---|---|---|
| Test of the different devices integrated in cardiospace IIThe different devices included in CARDIOSPACE II will be tested * Electrocardiogram * Vascular Doppler * LaserDoppler and iontophoresis * Brachial blood pressure * Continuous blood pressure recorded at the finger level * Ultrasound * Ambulatory Electrocardiogram / SAO2 (arterial oxygen saturation) | Device | CARDIOSPACE II |
Primary outcome
Quality of the ECG signal given by CARDIOSPACE II: scale
Time frame: Through study completion, an average of 6 months
ECG signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise
Quality of the vascular Doppler signal: scale
Time frame: Through study completion, an average of 6 months
Doppler signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise
Quality of the laser doppler signal: scale
Time frame: Through study completion, an average of 6 months
Laser Doppler signal will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise
Quality of the ultrasound images: scale
Time frame: Through study completion, an average of 6 months
Ultrasound images will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable image and 5 is a very clear image
Quality of the blood pressure wave: scale
Time frame: Through study completion, an average of 6 months
Blood pressure wave signal will be estimated by by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise
Quality of the ambulatory measurements (ECG / SAO2)
Time frame: Through study completion, an average of 6 months
ECG and SaO2 ambulatory measurements will be estimated by investigators using a scale (from 0 to 5) 0 is a uninterpretable signal and 5 is a very clear signal without noise
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 28 Jul 2021.
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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 Test of the different devices integrated in cardiospace II 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 8 inclusion and 7 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 28 Jul 2021. 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?
Quality of the ECG signal given by CARDIOSPACE II: scale (time frame: Through study completion, an average of 6 months). The study lists 6 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 28 Jul 2021.