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NCT00267462 Clinical Trial

Hypertrophic Myopathy in Children

Congenital Disorders Clinical Trial

Official title:
Retrospective Review of Hypertrophic Myopathy in Children

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00267462
Other study ID # 05-034
Secondary ID
Status Terminated
Phase N/A
First received December 19, 2005
Last updated May 3, 2007
Start date January 1996

Study information
Verified date May 2007
Source Children's Healthcare of Atlanta
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

The purpose of this study is to identify the patients seen in our practice who are seen with Hypertrophic Myopathy diagnosis in order to better understand the presenting characteristics of their disease, the diagnostic testing to determine the diagnosis, the methods used to follow the disease progression and management practices used in caring for these patients. The objectives of this data review will be an analysis to determine if there is a methodology that will foster improved diagnostic speed and accuracy, and determine the best management practices based on outcomes in these patients.

Description:

The charts of children followed at Sibley Heart Center of Children's Healthcare of Atlanta will be identified using the Mysis system and screening for the appropriate ICD-9 codes for the types of Hypertrophic Myopathy. These codes include: 425.1, 425.4, 425.7, 425.8, and 425.9. Screening will also be done for known anomalies that are associated with hypertrophic myopathy as seen in some syndromes and metabolic disorders.

Data Collection:

Age at presentation (DOB) History – Prenatal, Family, Current Surgical Procedures Physical Exam results EKG interpretation CXR results Echocardiography results MRI Results Holter monitors results Exercise testing results Radionuclear study results Spiral CT Study results Genetics Testing results Medication usage Enzyme replacement therapy usage Diagnostic laboratory results

Statistics:

A generalized linear model will be performed. Significance will be defined at P≤ 0.05.

Interim monitoring of accumulated data will be performed. One interim analysis will be performed after 3 months of accrual with additional analyses being performed at the end of data collection.

Demographic data will be summarized for all subjects. For each patient summary statistics will include the mean, standard deviation, frequency distribution, minimum, maximum and range.

Recruitment information / eligibility
Status Terminated
Enrollment 75
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Years
Eligibility Inclusion Criteria:

- seen at Sibley Heart Center, Children's Healthcare of Atlanta

- diagnosed with Hypertrophic Myopathy

Exclusion Criteria:

- those who do not meet inclusion criteria

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Healthcare of Atlanta Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

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