Trial record 2 of 212 for:    "Muscular dystrophy"

Cardiac Outcome Measures in Children With Muscular Dystrophy

This study has been completed.
Sponsor:
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
  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:


Further study details as provided by Cooperative International Neuromuscular Research Group:

Biospecimen Retention:   None Retained

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)
Detailed Description:

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

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 October 23, 2014