<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01712152</url>
  </required_header>
  <id_info>
    <org_study_id>EK 11-228- 0112</org_study_id>
    <nct_id>NCT01712152</nct_id>
  </id_info>
  <brief_title>Myocardial Involvement in Carriers of Duchenne Muscular Dystrophy: An MRI-study</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Rudolfstiftung</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oesterreichische Muskelforschung</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Rudolfstiftung</source>
  <brief_summary>
    <textblock>
      Carriers of Duchenne muscular dystrophy (DMD) often have no severe symptoms of the scelet&#xD;
      muscles, but they may develop a poor heart function due to the involvement of the heart&#xD;
      muscle. Ultrasound of the heart is recommended, but it can detect a cardiac affection only&#xD;
      after the heart has already become weaker. Cardiac magnetic resonance tomography can detect&#xD;
      myocardial fibrosis already at preserved heart function and may facilitate early therapy. In&#xD;
      our study, diagnosed carriers of DMD will undergo examinations of the heart by blood tests,&#xD;
      EKG, heart ultrasound and magnetic resonance at enrollment and after one year in order to&#xD;
      assess the extent of cardiac affection and its association with the clinical development.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>T1 mapping</measure>
    <time_frame>1 year</time_frame>
    <description>T1 mapping by MOLLI sequences will be performed and compared between study entry and one year follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>left ventricular function</measure>
    <time_frame>1 year</time_frame>
    <description>left ventricular function on MRI will be compared between study entry and one year follow-up</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Carrier of Duchenne Muscular Dystrophy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        data base of carriers of Duchenne muscular dystrophy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        genetic and/or histological identification as a carrier of DMD age above 18 years able and&#xD;
        willing to conform to the requirements of the study provided written informed consent&#xD;
        exclusion of pregnancy in women of childbearing potential&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Claustrophobia Excessive obesity to an extent where CMR cannot be performed Chronic renal&#xD;
        failure with a GFR &lt;30 ml/min/1,73m² Implanted pacemakers/defibrillators Severe arrhythmia&#xD;
        Inability to cooperate during the CMR Known intolerance to gadolinium Positive pregnancy&#xD;
        test Unable or unwilling to conform to the study protocol&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Wexberg, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Rudolfstiftung</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>2nd Medical Dept., Rudolfstiftung</name>
      <address>
        <city>Vienna</city>
        <zip>A-1030</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>October 3, 2016</last_update_submitted>
  <last_update_submitted_qc>October 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Rudolfstiftung</investigator_affiliation>
    <investigator_full_name>Paul Wexberg,MD</investigator_full_name>
    <investigator_title>Priv.-Doz.</investigator_title>
  </responsible_party>
  <keyword>Duchenne muscular dystrophy</keyword>
  <keyword>carrier</keyword>
  <keyword>cardiac MRI</keyword>
  <keyword>myocardial fibrosis</keyword>
  <keyword>female</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Dystrophies</mesh_term>
    <mesh_term>Muscular Dystrophy, Duchenne</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01712152
org study id: EK 11-228- 0112
nct id: NCT01712152
lead sponsor: 
collaborator: 
Carriers of Duchenne muscular dystrophy (DMD) often have no severe symptoms of the scelet
      muscles, but they may develop a poor heart function due to the involvement of the heart
      muscle. Ultrasound of the heart is recommended, but it can detect a cardiac affection only
      after the heart has already become weaker. Cardiac magnetic resonance tomography can detect
      myocardial fibrosis already at preserved heart function and may facilitate early therapy. In
      our study, diagnosed carriers of DMD will undergo examinations of the heart by blood tests,
      EKG, heart ultrasound and magnetic resonance at enrollment and after one year in order to
      assess the extent of cardiac affection and its association with the clinical development.
observational model: Cohort
time perspective: Prospective
measure: T1 mapping
time frame: 1 year
description: T1 mapping by MOLLI sequences will be performed and compared between study entry and one year follow-up
measure: left ventricular function
time frame: 1 year
description: left ventricular function on MRI will be compared between study entry and one year follow-up
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul Wexberg, MD
role: Study Director
affiliation: Hospital Rudolfstiftung
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Hospital Rudolfstiftung
investigator full name: Paul Wexberg,MD
investigator title: Priv.-Doz.
mesh term: Muscular Dystrophies
mesh term: Muscular Dystrophy, Duchenne