Myocardial PerfusionNCT02848703
Study " COFLORES "
A study testing Magnetic Resonance Imaging (MRI), phosphorus-31 Magnetic Resonance Spectroscopy and sodium-23 MRI in people with Myocardial Perfusion, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Myocardial perfusion is a major parameter characterizing the status of capillary circulation of the myocardium. Its quantification is possible using Magnetic Resonance Imaging (MRI) during the 1st pass of a contrast agent through the capillary system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Perfusion
- What is being tested?
- Magnetic Resonance Imaging (MRI), phosphorus-31 Magnetic Resonance Spectroscopy and sodium-23 MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jul 2016to 27 Oct 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- People having no heart disease or treatment referred to cardiology
- People having no cons -indications to MRI
- People having no cons -indications to gadolinium ;
- People not wearing implantable devices
- People not wearing metallic foreign bodies or risk (eg . Business of steel, etc .. )
- People having no cardiovascular risk factor
- Person subject to the social security scheme
- Nobody agreeing to participate in the study and who signed the informed consent
Who cannot join
- Refusal to go spontaneous or MRI because of claustrophobia important
- Trouble rhythm making MRI uninterpretable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study " COFLORES ":Imaging of Coronary Reserve Without Tracers
Myocardial perfusion is a major parameter characterizing the status of capillary circulation of the myocardium. Its quantification is possible using Magnetic Resonance Imaging (MRI) during the 1st pass of a contrast agent through the capillary system. This technique is radiation-free, but it is difficult to repeat measurements during a single exam. Also, a number of patients suffering from cardiac disease cannot receive contrast agent injections. The investigators have developed a totally non-invasive approach for quantifying myocardial perfusion. It is based on the magnetic labeling of arterial spins. Flowing into the capillaries (Arterial spin labeling, ASL).
Goal : The major goal of this research protocol is to validate a totally non-invasive method of myocardial blood flow quantification using MRI without contrast agent injection
- Conditions
- Myocardial Perfusion
- Being tested
- Magnetic Resonance Imaging (MRI), phosphorus-31 Magnetic Resonance Spectroscopy, sodium-23 MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Device
phosphorus-31 Magnetic Resonance SpectroscopyDevice
sodium-23 MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Experimental | Not described Receives: Device: Magnetic Resonance Imaging (MRI); Device: phosphorus-31 Magnetic Resonance Spectroscopy; Device: sodium-23 MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial perfusion
MRI based on the magnetic labeling of arterial spins
Measured: 1day
Secondary outcomes (2)
the myocardial energetic status
using phosphorus-31 Magnetic Resonance Spectroscopy
Measured: 1day
the myocardial sodium
using sodium-23 MRI
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study start26 Jul 2016
- Primary completion27 Feb 2019
- Study completion27 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial PerfusionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine GEINDRE, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848703
- Sponsor's protocol ID
- 2015-45
- Other IDs
- 2016-A00026-45
- Status last verified
- Nov 2022
- First submitted
- 26 Jul 2016
- Last updated
- 14 Nov 2022
- 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 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study " COFLORES ":Imaging of Coronary Reserve Without Tracers
- ClinicalTrials.gov ID
- NCT02848703
- Acronym / sponsor ID
- 2015-45
- Conditions
- Myocardial Perfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 26 Jul 2016 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 27 Oct 2022 (actual)
- First posted
- 28 Jul 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.
Myocardial perfusion is a major parameter characterizing the status of capillary circulation of the myocardium. Its quantification is possible using Magnetic Resonance Imaging (MRI) during the 1st pass of a contrast agent through the capillary system. This technique is radiation-free, but it is difficult to repeat measurements during a single exam. Also, a number of patients suffering from cardiac disease cannot receive contrast agent injections. The investigators have developed a totally non-invasive approach for quantifying myocardial perfusion. It is based on the magnetic labeling of arterial spins. Flowing into the capillaries (Arterial spin labeling, ASL).
Goal : The major goal of this research protocol is to validate a totally non-invasive method of myocardial blood flow quantification using MRI without contrast agent injection
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Experimental | Device: Magnetic Resonance Imaging (MRI), Device: phosphorus-31 Magnetic Resonance Spectroscopy, Device: sodium-23 MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- People having no heart disease or treatment referred to cardiology
- People having no cons -indications to MRI
- People having no cons -indications to gadolinium ;
- People not wearing implantable devices
- People not wearing metallic foreign bodies or risk (eg . Business of steel, etc .. )
Key exclusion criteria (2 listed)
- Refusal to go spontaneous or MRI because of claustrophobia important
- Trouble rhythm making MRI uninterpretable
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 |
|---|---|---|
| Magnetic Resonance Imaging (MRI) | Device | healthy volunteers |
| phosphorus-31 Magnetic Resonance Spectroscopy | Device | healthy volunteers |
| sodium-23 MRI | Device | healthy volunteers |
Primary outcome
Myocardial perfusion
Time frame: 1day
MRI based on the magnetic labeling of arterial spins
2 secondary outcomes
the myocardial energetic status
Time frame: 1day
the myocardial sodium
Time frame: 1day
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 14 Nov 2022.
- 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.
Catherine GEINDRE study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging (MRI), phosphorus-31 Magnetic Resonance Spectroscopy and sodium-23 MRI in people with Myocardial Perfusion, run by Assistance Publique Hopitaux De Marseille 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 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 14 Nov 2022. 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?
Myocardial perfusion (time frame: 1day). 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 14 Nov 2022.