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Cardiac Magnetic Resonance in Children With Muscular Dystrophy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01081080
First Posted: March 5, 2010
Last Update Posted: January 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by:
Cooperative International Neuromuscular Research Group
  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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Paula R. Clemens, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01081080     History of Changes
Other Study ID Numbers: PITT0110
First Submitted: March 4, 2010
First Posted: March 5, 2010
Last Update Posted: January 11, 2013
Last Verified: January 2013

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

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Dystrophies, Limb-Girdle
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked