IRM Cardiaque en Respiration Libre Pour Des Patients Atteints de Dystrophinopathie sévère

August 26, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France
Clinical, prospective and monocentric study aiming at assessing the feasibility of fibrosis detection and quantification (and of function assessment) during MRI without breath-holds in a population of adults and children with Duchenne myopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France
        • Service de médecin nucléaire / CHU Nancy Brabois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Dystophinopathy (Duchenne or severe Becker)
  • >8yo
  • with social insurance
  • informed consent

Exclusion Criteria:

  • arythmia
  • impossibility to undergo an MRI (pacemaker, ....)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnetic Resonance Cardiac Imaging (with Gadolinium)
Device: Magnetic Resonance Cardiac Imaging (with Gadolinium)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of exams correctly acquired (feasabiliy of the exam)
Time Frame: after the last inclusion
Was it possible to acquire the whole examination for every patient ?
after the last inclusion
Number of exams allowing a qualitative assessment of images by the physician
Time Frame: after the last MRI exam
The image quality allows a qualitative diagnosis ?
after the last MRI exam
Number of exams allowing a quantitative assessment of the diagnosis
Time Frame: after the last MRI examination
Did the image quality allow a quantitative assessment of the diagnosis ?
after the last MRI examination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of anatomic cardiac segments with significant fibrosis according to the assessment methods (conventional LGE, qualitative detection with GRICS, and quantiative measure with GRICS)
Time Frame: after the last inclusion
correlation between fibrosis information (conventional LGE, qualitative detection with GRICS, and quantiative measure with GRICS)
after the last inclusion
Number of cardiac segments with fibrosis and/or regional dysfunction
Time Frame: after the last inclusion
Correlation between fibrosis and regional function for each cardiac segment
after the last inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

June 3, 2013

First Submitted That Met QC Criteria

March 3, 2014

First Posted (Estimated)

March 5, 2014

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C13-04
  • 2013-A00179-36 (Registry Identifier: IDRCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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