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Cardiac Magnetic Resonance in Children With Muscular Dystrophy

Sponsor
Cooperative International Neuromuscular Research Group (Other)
Overall Status
Completed
CT.gov ID
NCT01081080
Collaborator
National Institutes of Health (NIH) (NIH)
20
Enrollment
2
Locations
18
Duration (Months)
10
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    PITT0110 - Cardiac Magnetic Resonance: A Parallel Protocol to Cardiac Outcome Measures in Children With Muscular Dystrophy
    Study Start Date :
    Apr 1, 2010
    Actual Primary Completion Date :
    Oct 1, 2011
    Actual Study Completion Date :
    Oct 1, 2011

    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:
      No
      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

      Locations

      Site City State Country Postal Code
      1 Children's National Medical Center Washington District of Columbia United States 20010
      2 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01081080
      Other Study ID Numbers:
      • PITT0110
      First Posted:
      Mar 5, 2010
      Last Update Posted:
      Jan 11, 2013
      Last Verified:
      Jan 1, 2013
      Keywords provided by , ,
      cardiac
      muscle
      pediatric
      dystrophy
      Additional relevant MeSH terms:
      Muscular Dystrophies
      Muscular Dystrophy, Duchenne
      Muscular Dystrophies, Limb-Girdle

      Study Results

      No Results Posted as of Jan 11, 2013