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Completed

NCT Number: NCT02848703

Study " COFLORES "

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

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Key information

Conditions

Myocardial Perfusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging (MRI)

Device

phosphorus-31 Magnetic Resonance Spectroscopy

Device

sodium-23 MRI

Device

Primary outcomes

  1. Myocardial perfusion

    Time frame: 1day

    MRI based on the magnetic labeling of arterial spins

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

Study " COFLORES ":Imaging of Coronary Reserve Without Tracers

Important dates

Study start
2016
Primary completion
2019
Study completion
2022
First posted
Jul 28, 2016
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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