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NCT01081080 Clinical Trial

Cardiac Magnetic Resonance in Children With Muscular Dystrophy

Duchenne Muscular Dystrophy Clinical Trial

Official title:
PITT0110 - Cardiac Magnetic Resonance: A Parallel Protocol to Cardiac Outcome Measures in Children With Muscular Dystrophy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01081080
Other study ID # PITT0110
Secondary ID
Status Completed
Phase N/A
First received March 4, 2010
Last updated January 10, 2013
Start date April 2010
Est. completion date October 2011

Study information
Verified date January 2013
Source Cooperative International Neuromuscular Research Group
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 18 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania
United States Children's National Medical Center Washington District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
Cooperative International Neuromuscular Research Group National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

See also
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