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CompletedNCT02848703Updated Nov 14, 2022

Study " COFLORES "

An interventional study of Magnetic Resonance Imaging (MRI) and phosphorus-31 Magnetic Resonance Spectroscopy in Myocardial Perfusion, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-14.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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

02

Conditions studied

  • Myocardial Perfusion
03

In context

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 700 studies on the registry; 144 are open to participants now.

Browse Assistance Publique Hopitaux De Marseille studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Refusal to go spontaneous or MRI because of claustrophobia important
  • Trouble rhythm making MRI uninterpretable
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    healthy volunteers

    Device: Magnetic Resonance Imaging (MRI) · Device: phosphorus-31 Magnetic Resonance Spectroscopy · Device: sodium-23 MRI

Interventions

  • DeviceMagnetic Resonance Imaging (MRI)
  • Devicephosphorus-31 Magnetic Resonance Spectroscopy
  • Devicesodium-23 MRI
06

What researchers measure

Primary outcomes

  1. Myocardial perfusion

    MRI based on the magnetic labeling of arterial spins

    Time frame: 1day

Secondary outcomes

  1. the myocardial energetic status

    using phosphorus-31 Magnetic Resonance Spectroscopy

    Time frame: 1day

  2. the myocardial sodium

    using sodium-23 MRI

    Time frame: 1day

07

Study locations

1 site
  • Assistance Publique Hopitaux de Marseille
    Marseille, 13354, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2016 to primary completion in Feb 2019, 31 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 26, 2016
First posted
Jul 28, 2016
StartActual
Jul 26, 2016
Primary completionActual
Feb 27, 2019
CompletionActual
Oct 27, 2022
Last update
Nov 14, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02848703
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Jul 28, 2016
Start date
Jul 26, 2016
Primary completion
Feb 27, 2019
Completion
Oct 27, 2022
Last update
Nov 14, 2022

Study contacts

Catherine GEINDRE
study director · Assistance Publique Hopitaux De Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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