Myocardial Involvement in Carriers of Duchenne Muscular Dystrophy: An MRI-study
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Purpose
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.
| Condition |
|---|
|
Carrier of Duchenne Muscular Dystrophy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
- T1 mapping [ Time Frame: 1 year ] [ Designated as safety issue: No ]T1 mapping by MOLLI sequences will be performed and compared between study entry and one year follow-up
- left ventricular function [ Time Frame: 1 year ] [ Designated as safety issue: No ]left ventricular function on MRI will be compared between study entry and one year follow-up
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
data base of carriers of Duchenne muscular dystrophy
Inclusion Criteria:
genetic and/or histological identification as a carrier of DMD age above 18 years able and willing to conform to the requirements of the study provided written informed consent exclusion of pregnancy in women of childbearing potential
Exclusion Criteria:
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
Contacts and Locations| Contact: Paul Wexberg, MD | +43-1-71165 ext 92277 | paul.wexberg@wienkav.at |
| Austria | |
| 2nd Medical Dept., Rudolfstiftung | Recruiting |
| Vienna, Austria, A-1030 | |
| Principal Investigator: Paul Wexberg, MD | |
| Sub-Investigator: Marion Avanzini, MD | |
More Information
No publications provided
| Responsible Party: | Paul Wexberg,MD, Priv.-Doz., Hospital Rudolfstiftung |
| ClinicalTrials.gov Identifier: | NCT01712152 History of Changes |
| Other Study ID Numbers: | EK 11-228- 0112 |
| Study First Received: | October 19, 2012 |
| Last Updated: | October 22, 2012 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by Hospital Rudolfstiftung:
|
Duchenne muscular dystrophy carrier cardiac MRI myocardial fibrosis female |
Additional relevant MeSH terms:
|
Muscular Dystrophy, Duchenne Muscular Dystrophies Muscular Disorders, Atrophic Muscular Diseases Musculoskeletal Diseases |
Neuromuscular Diseases Nervous System Diseases Genetic Diseases, X-Linked Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 16, 2013