Cardiac Outcome Measures in Children With Muscular Dystrophy

Sponsor

Cooperative International Neuromuscular Research Group (Other)

Overall Status

Completed

CT.gov ID

NCT01066455

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Locations

Duration (Months)

9.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the research study is to evaluate different cardiac measures that are obtained by echocardiographic tests in patients with muscular dystrophy.

Condition or Disease	Intervention/Treatment	Phase
Duchenne Muscular Dystrophy Becker Muscular Dystrophy Limb Girdle Muscular Dystrophy

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.

Study Design

Study Type:

Observational

Actual Enrollment :

48 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

PITT1109: Cardiac Outcome Measures in Children With Muscular Dystrophy

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of California Davis	Sacramento	California	United States
2	Children's National Medical Center	Washington	District of Columbia	United States
3	Washington University St. Louis	St. Louis	Missouri	United States
4	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
5	Texas Children's Hospital	Houston	Texas	United States