Back to resultsIRM Cardiaque en Respiration Libre Pour Des Patients Atteints de Dystrophinopathie sévère
Primary Purpose
Duchenne or Severe Becker Myopathy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetic Resonance Cardiac Imaging (with Gadolinium)
Sponsored by
About this trial
This is an interventional diagnostic trial for Duchenne or Severe Becker Myopathy focused on measuring MRI, free-breathing acquisitions, myopathy, fibrosis assessment, function
Eligibility Criteria
Inclusion Criteria:
- Dystophinopathy (Duchenne or severe Becker)
- >8yo
- with social insurance
- informed consent
Exclusion Criteria:
- arythmia
- impossibility to undergo an MRI (pacemaker, ....)
Sites / Locations
- Service de médecin nucléaire / CHU Nancy Brabois
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Magnetic Resonance Cardiac Imaging (with Gadolinium)
Arm Description
Outcomes
Primary Outcome Measures
Number of exams correctly acquired (feasabiliy of the exam)
Was it possible to acquire the whole examination for every patient ?
Number of exams allowing a qualitative assessment of images by the physician
The image quality allows a qualitative diagnosis ?
Number of exams allowing a quantitative assessment of the diagnosis
Did the image quality allow a quantitative assessment of the diagnosis ?
Secondary Outcome Measures
Number of anatomic cardiac segments with significant fibrosis according to the assessment methods (conventional LGE, qualitative detection with GRICS, and quantiative measure with GRICS)
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
Correlation between fibrosis and regional function for each cardiac segment
Full Information
NCT ID
NCT02078076
First Posted
June 3, 2013
Last Updated
February 23, 2016
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT02078076
Brief Title
IRM Cardiaque en Respiration Libre Pour Des Patients Atteints de Dystrophinopathie sévère
Official Title
IRM Cardiaque en Respiration Libre Pour Des Patients Atteints de Dystrophinopathie sévère
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Duchenne or Severe Becker Myopathy
Keywords
MRI, free-breathing acquisitions, myopathy, fibrosis assessment, function
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnetic Resonance Cardiac Imaging (with Gadolinium)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Cardiac Imaging (with Gadolinium)
Primary Outcome Measure Information:
Title
Number of exams correctly acquired (feasabiliy of the exam)
Description
Was it possible to acquire the whole examination for every patient ?
Time Frame
after the last inclusion
Title
Number of exams allowing a qualitative assessment of images by the physician
Description
The image quality allows a qualitative diagnosis ?
Time Frame
after the last MRI exam
Title
Number of exams allowing a quantitative assessment of the diagnosis
Description
Did the image quality allow a quantitative assessment of the diagnosis ?
Time Frame
after the last MRI examination
Secondary Outcome Measure Information:
Title
Number of anatomic cardiac segments with significant fibrosis according to the assessment methods (conventional LGE, qualitative detection with GRICS, and quantiative measure with GRICS)
Description
correlation between fibrosis information (conventional LGE, qualitative detection with GRICS, and quantiative measure with GRICS)
Time Frame
after the last inclusion
Title
Number of cardiac segments with fibrosis and/or regional dysfunction
Description
Correlation between fibrosis and regional function for each cardiac segment
Time Frame
after the last inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Dystophinopathy (Duchenne or severe Becker)
>8yo
with social insurance
informed consent
Exclusion Criteria:
arythmia
impossibility to undergo an MRI (pacemaker, ....)
Facility Information:
Facility Name
Service de médecin nucléaire / CHU Nancy Brabois
City
Vandoeuvre
Country
France
12. IPD Sharing Statement
Learn more about this trial
IRM Cardiaque en Respiration Libre Pour Des Patients Atteints de Dystrophinopathie sévère
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