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Completed

NCT Number: NCT02078076

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

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.

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Key information

Conditions

Duchenne or Severe Becker Myopathy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fibrosis Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de médecin nucléaire / CHU Nancy Brabois

Vandœuvre-lès-Nancy, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Magnetic Resonance Cardiac Imaging (with Gadolinium)

Device

Primary outcomes

  1. 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 ?

  2. 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 ?

  3. 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 ?

Secondary outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 5, 2014
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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