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Cardiac Magnetic Resonance in Children With Muscular Dystrophy

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Cooperative International Neuromuscular Research Group
ClinicalTrials.gov Identifier:
NCT01081080
First received: March 4, 2010
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

This protocol will exploit novel state of the art cardiovascular magnetic resonance techniques to examine important changes in the heart in children with muscular dystrophy. The purpose of this study is to compare cardiac magnetic resonance (CMR) with the collected cardiac outcome data obtained in protocol: PITT1109 - Cardiac Outcome Measures in Children with Muscular Dystrophy.


Condition
Duchenne Muscular Dystrophy
Becker Muscular Dystrophy
Limb Girdle Muscular Dystrophy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PITT0110 - Cardiac Magnetic Resonance: A Parallel Protocol to Cardiac Outcome Measures in Children With Muscular Dystrophy

Resource links provided by NLM:

U.S. FDA Resources

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

Estimated Enrollment: 20
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
  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

Participants will be recruited from the parallel protocol: PITT1109 Cardiac Outcome Measures in Children with Muscular Dystrophy

Criteria

Inclusion Criteria:

  • Participant enrolled in the CINRG study: PITT1109 - Cardiac Outcome Measures in Children with Muscular Dystrophy

Exclusion Criteria:

  • Pregnant woman (when uncertain, participants will undergo urine testing) or lactating women
  • Decompensated congestive heart failure (unable to lie flat during CMR)
  • Impaired renal excretory function (calculated Glomerular Filtration Rate less than 30mL/min)

  • Contra-indications to Magnetic Resonance Imaging:

    • Cardiac pacemaker or implantable defibrillator
    • Cerebral aneurysm clip
    • Neural stimulator
    • Metallic ocular foreign body
    • Harrington-rod
    • Any implanted device (i.e. insulin pump, drug infusion device)
    • Claustrophobia
    • Metal shrapnel or bullet
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081080

Locations
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Cooperative International Neuromuscular Research Group
National Institutes of Health (NIH)
Investigators
Study Chair: Paula R Clemens, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Dr. Paula R. Clemens, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01081080     History of Changes
Other Study ID Numbers: PITT0110
Study First Received: March 4, 2010
Last Updated: January 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cooperative International Neuromuscular Research Group:
cardiac
muscle
pediatric
dystrophy

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 June 18, 2013