Study " COFLORES "
2 other identifiers
interventional
53
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2016
CompletedStudy Start
First participant enrolled
July 26, 2016
CompletedFirst Posted
Study publicly available on registry
July 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2022
CompletedNovember 14, 2022
November 1, 2022
2.6 years
July 26, 2016
November 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Myocardial perfusion
MRI based on the magnetic labeling of arterial spins
1day
Secondary Outcomes (2)
the myocardial energetic status
1day
the myocardial sodium
1day
Study Arms (1)
healthy volunteers
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Refusal to go spontaneous or MRI because of claustrophobia important
- Trouble rhythm making MRI uninterpretable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Catherine GEINDRE
Assistance Publique Hopitaux De Marseille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2016
First Posted
July 28, 2016
Study Start
July 26, 2016
Primary Completion
February 27, 2019
Study Completion
October 27, 2022
Last Updated
November 14, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share