Cardiac Magnetic Resonance in Children With Muscular Dyst... | NCT01081080

Studies
Cardiac Magnetic Resonance in Children With Muscular Dystrophy

NCT01081080

Sponsor

Cooperative International Neuromuscular Research Group

Status

Completed

Last Update Posted

Jan 11, 2013Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Duchenne Muscular Dystrophy
Becker Muscular Dystrophy
Limb Girdle Muscular Dystrophy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Mar 4, 2010

First Submission Date that Met QC Criteria

Mar 4, 2010

First Posted Date

Mar 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2013

Last Update Posted Date

Jan 11, 2013Estimated

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paula R Clemens, MD	University of Pittsburgh	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's National Medical Center		Washington D.C.	District of Columbia	20010	United States
University of Pittsburgh

Condition Browse Module

MeSH Terms

ID	Term
D020388	Muscular Dystrophy, Duchenne
D049288	Muscular Dystrophies, Limb-Girdle

Ancestor Terms

ID	Term
D009136	Muscular Dystrophies
D020966	Muscular Disorders, Atrophic
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided