MedPath

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

Not Applicable
Completed
Conditions
Duchenne or Severe Becker Myopathy
Registration Number
NCT02078076
Lead Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
22
Inclusion Criteria
  • Dystophinopathy (Duchenne or severe Becker)
  • >8yo
  • with social insurance
  • informed consent
Exclusion Criteria
  • arythmia
  • impossibility to undergo an MRI (pacemaker, ....)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
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 physicianafter the last MRI exam

The image quality allows a qualitative diagnosis ?

Number of exams allowing a quantitative assessment of the diagnosisafter the last MRI examination

Did the image quality allow a quantitative assessment of the diagnosis ?

Secondary Outcome Measures
NameTimeMethod
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 dysfunctionafter the last inclusion

Correlation between fibrosis and regional function for each cardiac segment

Trial Locations

Locations (1)

Service de médecin nucléaire / CHU Nancy Brabois

🇫🇷

Vandoeuvre, France

Service de médecin nucléaire / CHU Nancy Brabois
🇫🇷Vandoeuvre, France
© Copyright 2025. All Rights Reserved by MedPath