Study " COFLORES "

Myocardial Perfusion Clinical Trial

Official title:

Study " COFLORES ":Imaging of Coronary Reserve Without Tracers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848703
• Other study ID #: 2015-45
• Secondary ID: 2016-A00026-45
• Status: Completed
• Phase: N/A
• Start date: July 26, 2016
• Est. completion date: October 27, 2022

Study information

• Verified date: November 2022
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 27, 2022
• Est. primary completion date: February 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myocardial Perfusion

Intervention

Device:
• Magnetic Resonance Imaging (MRI)

• phosphorus-31 Magnetic Resonance Spectroscopy

• sodium-23 MRI

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial perfusion	MRI based on the magnetic labeling of arterial spins	1day
Secondary	the myocardial energetic status	using phosphorus-31 Magnetic Resonance Spectroscopy	1day
Secondary	the myocardial sodium	using sodium-23 MRI	1day