Study " COFLORES "

Not Applicable

Completed

• Conditions: Myocardial Perfusion
• Interventions: Device: Magnetic Resonance Imaging (MRI); Device: phosphorus-31 Magnetic Resonance Spectroscopy; Device: sodium-23 MRI

• Registration Number: NCT02848703
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-26
• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-28
• Primary Completion: 2019-02-27
• Study Completion: 2022-10-27
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
healthy volunteers	Magnetic Resonance Imaging (MRI)	-
healthy volunteers	phosphorus-31 Magnetic Resonance Spectroscopy	-
healthy volunteers	sodium-23 MRI	-

Primary Outcome Measures

Name	Time	Method
Myocardial perfusion	1day	MRI based on the magnetic labeling of arterial spins

Secondary Outcome Measures

Name	Time	Method
the myocardial sodium	1day	using sodium-23 MRI
the myocardial energetic status	1day	using phosphorus-31 Magnetic Resonance Spectroscopy

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France