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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02078076

Enrollment

Registered

2014-03-05

Start date

2013-06-30

Completion date

2015-11-30

Last updated

2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duchenne or Severe Becker Myopathy

Keywords

MRI, free-breathing acquisitions, myopathy, fibrosis assessment, function

Brief summary

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.

Interventions

DEVICEMagnetic Resonance Cardiac Imaging (with Gadolinium)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026