Study " COFLORES "

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

Study Overview

• Status: Completed
• Conditions: Myocardial Perfusion
• Intervention / Treatment: Device: Magnetic Resonance Imaging (MRI); Device: phosphorus-31 Magnetic Resonance Spectroscopy; Device: sodium-23 MRI

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: healthy volunteers	Device: Magnetic Resonance Imaging (MRI); Device: phosphorus-31 Magnetic Resonance Spectroscopy; Device: sodium-23 MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial perfusion	MRI based on the magnetic labeling of arterial spins	1day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the myocardial energetic status	using phosphorus-31 Magnetic Resonance Spectroscopy	1day
the myocardial sodium	using sodium-23 MRI	1day

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 26, 2016
• Primary Completion (ACTUAL): February 27, 2019
• Study Completion (ACTUAL): October 27, 2022

Study Registration Dates

• First Submitted: July 26, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (ESTIMATE): July 28, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2015-45; 2016-A00026-45 (REGISTRY: ansm)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO