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| Sponsored by: |
Indiana University School of Medicine |
|---|---|
| Information provided by: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00622453 |
Purpose
Adult myotonic muscular dystrophy (Steinert's disease) is the most common inherited neuromuscular disorder. Cardiac rhythm disturbances occur frequently in this disease state and may be responsible for up to one-third of deaths. In this study, we intend to evaluate the utility of non-invasive electrocardiographic screening methods and history in predicting serious arrhythmic events.
| Condition | Intervention |
|---|---|
|
Muscular Dystrophy Arrhythmia Sudden Cardiac Death |
Other: Screening |
| Study Type: | Observational |
| Official Title: | A Registry of Arrhythmias in Myotonic Muscular Dystrophy |
| Enrollment: | 448 |
| Study Start Date: | September 1996 |
| Estimated Study Completion Date: | December 2009 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Individuals with myotonic muscular dystrophy to evaluate the heart rhythm disturbances.
|
Other: Screening
Electrocardiography
|
The long term objectives of this population study is a more defined natural history, optimal diagnostic testing methodology, and methods of therapy for arrhythmias in individuals with myotonic muscular dystrophy. The goal is a more adequate definition of appropriate diagnosis and therapy for arrhythmias in order to decrease the likelihood of cardiac morbidity and mortality in this disorder.
The specific aims of the study involve an initial survey of individuals with myotonic muscular dystrophy detailing multiple factors. Non-invasive electrocardiographic testing will be done. Using this initial data and subsequent follow-up data collected yearly the cohort of patients will be followed as to arrhythmia development over a minimum of five years and likely longer with a long-term registry and evaluation of National Death Records and Ancestry.com. This project is unique in that it characterizes a non-neurologic abnormality associated with a neuromuscular disease, myotonic muscular dystrophy.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patient Recruitment: Will take place at the 230 hospital-affiliated MDA neuromuscular clinics. Individuals with myotonic dystrophy will be identified in the MDA clinics these will be asked to participate in the study.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Indiana | |
| Krannert Institute of Cardiology | |
| Indianapolis, Indiana, United States, 46202 | |
| Principal Investigator: | William Groh, MD | Indiana School of Medicine |
More Information
| Responsible Party: | Indiana University ( William Groh, MD ) |
| Study ID Numbers: | 9609-31 |
| Study First Received: | February 13, 2008 |
| Last Updated: | February 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00622453 |
| Health Authority: | United States: Institutional Review Board |
|
Death Heart Diseases Heart Arrest Muscular Dystrophies Muscular Diseases Muscular Disorders, Atrophic Musculoskeletal Diseases |
Neuromuscular Diseases Genetic Diseases, Inborn Death, Sudden Atrophy Muscular dystrophy Death, Sudden, Cardiac Arrhythmias, Cardiac |
|
Pathologic Processes Nervous System Diseases Cardiovascular Diseases |
