Trial document




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  DRKS00004539

Trial Description

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Title

DMD-Carriers: Detection of Cardiomyopathy through Cardiac MRI and Echocardiography

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The group of carriers of the Duchenne Muscular Dystrophy has not been looked at in terms of a systematic work up of specific conditions concerning the heart. Having this in mind, we designed this study to obtain data regarding the heart and it´s function in female carriers of Duchenne´s Muscular Dystrophy.
We combine common standardised tests for mobility and strength in a regular physical examination with the use of standard procedures like ECG, 24h- ECG, 6 Minute Walk Test, an ultrasound of the heart and a magnetic resonance imaging (MRI) of the heart.
Inclusion criteria are positive genetic analysis for status of Duchenne´s Dystrophy carrier, minimum age of 14 years.
We hope to identify structural and functional changes in the heart muscle of this group of people.

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Brief Summary in Scientific Language

The study mentioned above is a monocentric, national, cross- sectional trial. Inclusion criteria are confirmed positive genetic analysis for carrier status of Duchenne Muscular Dystrophy in females, minimum age 14 years. The protocol includes a combination of both physical ( e.g. Medical Research Council Muscular Test) and apparative examinations, such as ECG, Echocardiography and Cardiac MRI.
The main interest is to identify specific modifications in the myocardium of this population ad maybe develope a new approach to recommendations regarding a preventional cardiac follow up in Duchenne- carriers.

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Organizational Data

  •   DRKS00004539
  •   2012/11/30
  •   [---]*
  •   yes
  •   Approved
  •   12-5117-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Carrier of Duchenne Muscular Dystrophy
  •   I42.9 -  Cardiomyopathy, unspecified
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Interventions/Observational Groups

  •   Following the protocol, the physical exam is structured by a form documenting standardised tests like e.g. MRC muscular functional test.
    The apparative diagnostics include ECG, 24ECG, 6 Minute Walk Test, Echocardiography and Cardiac MRI.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Identification of Duchenne carriers´specific changes/abnormalities in Cardiac MRI and echocardiography.

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Secondary Outcome

Developement of SOPs regarding the tested methods in this group of people, using the data from this trial.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/02/07
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   14   Years
  •   no maximum age
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Additional Inclusion Criteria

Confirmed positive analysis for carrier status of Duchenne Muscular Dystrophy.
Minimum age 14 years.

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Exclusion Criteria

Lack of confirmed positive analysis for carrier status of Duchenne Muscular Dystrophy.
Age under 14 years.
Any psychological or physical condition implying a contraindication to any of the examinations included in the trial protocol.

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Addresses

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    • Universitätsklinikum Essen Zentrum für Kinder- und Jugendmedizin Klinik III, Bereiche Kinderkardiologie und Rheumatologie
    • Mr.  Dr. med.  Ulrich  Neudorf 
    • Hufelandstrasse 55
    • 45122  Essen
    • Germany
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    • Universitätsklinikum Essen Zentrum für Kinder- und Jugendmedizin Klinik III, Bereich Kinderkardiologie
    • Ms.  Anne  Schönecker 
    • Hufelandstrasse 55
    • 45122  Essen
    • Germany
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    • Universitätsklinikum Essen Zentrum für Kinder- und Jugendmedizin Klinik III, Bereich Kinderkardiologie
    • Ms.  Anne  Schönecker 
    • Hufelandstrasse 55
    • 45122  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Essen Zentrum für Kinder- und Jugendmedizin Bereiche Kinderkardiologie und Rheumatologie
    • Mr.  Dr. med.  Ulrich  Neudorf 
    • Hufelandstr.55
    • 45122  Essen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/11/14
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.