Cardiac Outcome Measures in Children With Muscular Dystrophy

This study has been completed.

Sponsor:

Collaborator:

National Institutes of Health (NIH)

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

History of Changes

Tracking Information
First Received Date ^ICMJE	February 9, 2010
Last Updated Date	January 10, 2013
Start Date ^ICMJE	January 2010
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01066455 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Cardiac Outcome Measures in Children With Muscular Dystrophy
Official Title ^ICMJE	PITT1109: Cardiac Outcome Measures in Children With Muscular Dystrophy
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.
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 Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: None Retained Description: Prospective collection of blood sample for BNP measurements.
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)
Condition ^ICMJE	Duchenne Muscular Dystrophy Becker Muscular Dystrophy Limb Girdle Muscular Dystrophy
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	48
Completion Date	May 2012
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	8 Years to 18 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01066455
Other Study ID Numbers ^ICMJE	PITT1109
Has Data Monitoring Committee	Yes
Responsible Party	Cooperative International Neuromuscular Research Group
Study Sponsor ^ICMJE	Cooperative International Neuromuscular Research Group
Collaborators ^ICMJE	National Institutes of Health (NIH)
Investigators ^ICMJE	Not Provided
Information Provided By	Cooperative International Neuromuscular Research Group
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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