Study " COFLORES "

NCT ID: NCT02848703

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-26

Study Completion Date

2022-10-27

Brief Summary

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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

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Conditions

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Myocardial Perfusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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healthy volunteers

Group Type EXPERIMENTAL

Magnetic Resonance Imaging (MRI)

Intervention Type DEVICE

phosphorus-31 Magnetic Resonance Spectroscopy

Intervention Type DEVICE

sodium-23 MRI

Intervention Type DEVICE

Interventions

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Magnetic Resonance Imaging (MRI)

Intervention Type DEVICE

phosphorus-31 Magnetic Resonance Spectroscopy

Intervention Type DEVICE

sodium-23 MRI

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine GEINDRE

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

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Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2016-A00026-45

Identifier Type: REGISTRY

Identifier Source: secondary_id

2015-45

Identifier Type: -

Identifier Source: org_study_id

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