Cardiac Outcome Measures in Children With Muscular Dystrophy
This study has been completed.
Sponsor:
Cooperative International Neuromuscular Research Group
Collaborator:
Information provided by (Responsible Party):
Cooperative International Neuromuscular Research Group
ClinicalTrials.gov Identifier:
NCT01066455
First received: February 9, 2010
Last updated: January 10, 2013
Last verified: January 2013
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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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Duchenne and Becker muscular dystrophy
limb-girdle muscular dystrophy
MedlinePlus related topics:
Muscular Dystrophy
Genetic and Rare Diseases Information Center resources:
Becker Muscular Dystrophy
Duchenne Muscular Dystrophy
Limb-girdle Muscular Dystrophy
Limb-girdle Muscular Dystrophy, Type 2C
Muscular Dystrophy
U.S. FDA Resources
Further study details as provided by Cooperative International Neuromuscular Research Group:
Biospecimen Retention: None Retained
Detailed Description:
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 |
Study Population
8 to 18 years old Confirmed diagnosis of Duchenne, Becker, or autosomal recessive limb-girdle muscular dystrophy (LGMD: 2C-2F and 2I)
Criteria
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066455
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066455
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 | |
Sponsors and Collaborators
Cooperative International Neuromuscular Research Group
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 Dystrophies Muscular Dystrophies, Limb-Girdle Muscular Dystrophy, Duchenne Genetic Diseases, Inborn Genetic Diseases, X-Linked |
Muscular Diseases Muscular Disorders, Atrophic Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases |
ClinicalTrials.gov processed this record on March 03, 2015