NCT02848703

Completed

Study " COFLORES "

Assistance Publique Hopitaux De Marseille Source

Compare

Other study identifiers

Sponsor study identifier

2015-45

Secondary identifiers

2016-A00026-45

REGISTRY · ansm

Study Type

interventional

Actual enrollment (reported)

53

Locations

1 country

Sites

1

Timeline

Study Start

July 26, 2016

Actual (reported)

Primary Completion

February 27, 2019

Actual (reported)

Study Completion

October 27, 2022

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 53 participants
Study completion date: October 27, 2022
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
July 26, 2016
Actual (reported)
Study Start
July 26, 2016
Actual (reported)
First Posted
July 28, 2016
Actual (reported)
Primary Completion
February 27, 2019
Actual (reported)
Study Completion
October 27, 2022
Actual (reported)

Last Updated: November 14, 2022
Status Verified: November 2022
Last Update Submitted: November 9, 2022

Conditions

Myocardial Perfusion

Outcome Measures

Primary Outcomes (1)

Myocardial perfusion
MRI based on the magnetic labeling of arterial spins
1day

Secondary Outcomes (2)

the myocardial energetic status
1day
the myocardial sodium
1day

Study Arms (1)

healthy volunteers

EXPERIMENTAL

Device: Magnetic Resonance Imaging (MRI)Device: phosphorus-31 Magnetic Resonance SpectroscopyDevice: sodium-23 MRI

Interventions

Magnetic Resonance Imaging (MRI)Device

healthy volunteers

phosphorus-31 Magnetic Resonance SpectroscopyDevice

healthy volunteers

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

People having no heart disease or treatment referred to cardiology
People having no cons -indications to MRI

Sponsors & Collaborators

Assistance Publique Hopitaux De Marseille
Otherlead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

Catherine GEINDRE
Assistance Publique Hopitaux De Marseille
STUDY DIRECTOR

Enrollment

53 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 26, 2016

First Posted

July 28, 2016

Study Start

July 26, 2016

Actual (reported)

Primary Completion

NCT02816645

One-year Follow-up of Iron in Basal Ganglia - R2*: a Biomarker of Parkinson's Disease Progression?

Not ApplicableUnknown

NCT02977663

Imaging Multiparametric/Multimodality for Lungcancer

Not ApplicableUnknown

NCT02001675

Comparison of Both Metabolic and Functional Effects Induced by Two Neuromuscular Electrical Stimulation Protocols: A Comprehensive Approach Using Magnetic Resonance Imaging and Spectroscopy

Not ApplicableUnknown

NCT03589365

Preterm Birth and Long Term Consequences on Myocardial Functions and Structure

Not ApplicableUnknown

NCT02018718

Development and Validation Phase of Diffusion Tensor Imaging and Arterial Spin Labelling at 3 Tesla Using a Long-term Effort Model Applicable to Skeletal Muscle Characterization.

Not ApplicableCompleted

NCT01100008

Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion

Not ApplicableCompleted

sodium-23 MRIDevice

healthy volunteers

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

You may not qualify if:

Refusal to go spontaneous or MRI because of claustrophobia important
Trouble rhythm making MRI uninterpretable

Contact the study team to confirm eligibility.

February 27, 2019

Actual (reported)

Study Completion

October 27, 2022

Actual (reported)

Last Updated

November 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02848703
Data provider: ClinicalTrials.gov
Source updated: 2022-11-14
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:30 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

healthy volunteers

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations