Myocardial Involvement in Carriers of Duchenne Muscular Dystrophy: An MRI-study
1 other identifier
observational
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 19, 2012
CompletedFirst Posted
Study publicly available on registry
October 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedOctober 4, 2016
October 1, 2016
1.5 years
October 19, 2012
October 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
T1 mapping
T1 mapping by MOLLI sequences will be performed and compared between study entry and one year follow-up
1 year
Secondary Outcomes (1)
left ventricular function
1 year
Eligibility Criteria
data base of carriers of Duchenne muscular dystrophy
You may not qualify if:
- Claustrophobia Excessive obesity to an extent where CMR cannot be performed Chronic renal failure with a GFR \<30 ml/min/1,73m² Implanted pacemakers/defibrillators Severe arrhythmia Inability to cooperate during the CMR Known intolerance to gadolinium Positive pregnancy test Unable or unwilling to conform to the study protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Rudolfstiftunglead
- Oesterreichische Muskelforschungcollaborator
Study Sites (1)
2nd Medical Dept., Rudolfstiftung
Vienna, A-1030, Austria
Related Publications (1)
Wexberg P, Avanzini M, Mascherbauer J, Pfaffenberger S, Freudenthaler B, Bittner R, Bernert G, Weidinger F. Myocardial late gadolinium enhancement is associated with clinical presentation in Duchenne muscular dystrophy carriers. J Cardiovasc Magn Reson. 2016 Sep 22;18(1):61. doi: 10.1186/s12968-016-0281-y.
PMID: 27660108DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paul Wexberg, MD
Hospital Rudolfstiftung
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Priv.-Doz.
Study Record Dates
First Submitted
October 19, 2012
First Posted
October 23, 2012
Study Start
October 1, 2012
Primary Completion
April 1, 2014
Study Completion
September 1, 2015
Last Updated
October 4, 2016
Record last verified: 2016-10