Cardiac Outcome Measures in Children With Muscular Dystrophy
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Purpose
The purpose of the research study is to evaluate different cardiac measures that are obtained by echocardiographic tests in patients with muscular dystrophy.
| Condition |
|---|
|
Duchenne Muscular Dystrophy Becker Muscular Dystrophy Limb Girdle Muscular Dystrophy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | PITT1109: Cardiac Outcome Measures in Children With Muscular Dystrophy |
Prospective collection of blood sample for BNP measurements.
| Enrollment: | 48 |
| Study Start Date: | January 2010 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
The research study will include 50 participants aged 8 to 18 years old (before 18th birthday) with Duchenne, Becker, or autosomal recessive limb-girdle (specifically: LGMD 2C-2F and 2I) muscular dystrophies.
Participants will be seen in one of five Cooperative International Neuromuscular Research Group (CINRG) centers located in the United States.
All study assessments will be completed in the same day and include reviewing past medical and surgical history, collecting vital signs, collecting cardiac measures through echocardiographic tests.
Eligibility| Ages Eligible for Study: | 8 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
8 to 18 years old Confirmed diagnosis of Duchenne, Becker, or autosomal recessive limb-girdle muscular dystrophy (LGMD: 2C-2F and 2I)
Inclusion Criteria:
- Participants must be between the ages of 8 and 18 years old
- Confirmed diagnosis of muscular dystrophy (DMD, BMD, or LGMD 2C-2F and 2I)
Exclusion Criteria:
- Investigator assessment of inability to comply with protocol
- History of a congenital cardiac defect or other cardiac disease unrelated to muscular dystrophy
Contacts and Locations| United States, California | |
| University of California Davis | |
| Sacramento, California, United States | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States | |
| United States, Missouri | |
| Washington University St. Louis | |
| St. Louis, Missouri, United States | |
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Texas | |
| Texas Children's Hospital | |
| Houston, Texas, United States | |
More Information
No publications provided
| Responsible Party: | Cooperative International Neuromuscular Research Group |
| ClinicalTrials.gov Identifier: | NCT01066455 History of Changes |
| Other Study ID Numbers: | PITT1109 |
| Study First Received: | February 9, 2010 |
| Last Updated: | January 10, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Cooperative International Neuromuscular Research Group:
|
Cardiac Muscular Dystrophy Prospective Pediatric Echocardiogram |
Additional relevant MeSH terms:
|
Muscular Dystrophy, Duchenne Muscular Dystrophies Muscular Dystrophies, Limb-Girdle 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