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Study " COFLORES "

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ClinicalTrials.gov Identifier: NCT02848703
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Myocardial Perfusion Device: Magnetic Resonance Imaging (MRI) Device: phosphorus-31 Magnetic Resonance Spectroscopy Device: sodium-23 MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study " COFLORES ":Imaging of Coronary Reserve Without Tracers
Actual Study Start Date : July 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: healthy volunteers Device: Magnetic Resonance Imaging (MRI)
Device: phosphorus-31 Magnetic Resonance Spectroscopy
Device: sodium-23 MRI



Primary Outcome Measures :
  1. Myocardial perfusion [ Time Frame: 1day ]
    MRI based on the magnetic labeling of arterial spins


Secondary Outcome Measures :
  1. the myocardial energetic status [ Time Frame: 1day ]
    using phosphorus-31 Magnetic Resonance Spectroscopy

  2. the myocardial sodium [ Time Frame: 1day ]
    using sodium-23 MRI



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848703


Contacts
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Contact: ALEXIS JACQUIER alexis.jacquier@ap-hm.fr
Contact: Alexandra GIULIANI alexandra.giuliani@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: ALEXIS JACQUIER, MD       ajacquier@ap-hm.fr   
Principal Investigator: alexis jacquier, MD         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Catherine GEINDRE Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02848703     History of Changes
Other Study ID Numbers: 2015-45
2016-A00026-45 ( Registry Identifier: ansm )
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No