Study " COFLORES "

November 9, 2022 updated by: Assistance Publique Hopitaux De Marseille

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 1day
MRI based on the magnetic labeling of arterial spins
1day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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