NCT01066455

Brief Summary

The purpose of the research study is to evaluate different cardiac measures that are obtained by echocardiographic tests in patients with muscular dystrophy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 11, 2013

Status Verified

January 1, 2013

Enrollment Period

2.3 years

First QC Date

February 9, 2010

Last Update Submit

January 10, 2013

Conditions

Keywords

CardiacMuscular DystrophyProspectivePediatricEchocardiogram

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

8 to 18 years old Confirmed diagnosis of Duchenne, Becker, or autosomal recessive limb-girdle muscular dystrophy (LGMD: 2C-2F and 2I)

You may qualify if:

  • Participants must be between the ages of 8 and 18 years old
  • Confirmed diagnosis of muscular dystrophy (DMD, BMD, or LGMD 2C-2F and 2I)

You may not qualify if:

  • Investigator assessment of inability to comply with protocol
  • History of a congenital cardiac defect or other cardiac disease unrelated to muscular dystrophy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of California Davis

Sacramento, California, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, United States

Location

Washington University St. Louis

St Louis, Missouri, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Texas Children's Hospital

Houston, Texas, United States

Location

Biospecimen

Retention: NONE RETAINED

Prospective collection of blood sample for BNP measurements.

MeSH Terms

Conditions

Muscular Dystrophy, DuchenneMuscular Dystrophies, Limb-GirdleMuscular Dystrophies

Condition Hierarchy (Ancestors)

Muscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2010

First Posted

February 10, 2010

Study Start

January 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

January 11, 2013

Record last verified: 2013-01

Locations