Hypertrophic Myopathy in Children
|ClinicalTrials.gov Identifier: NCT00267462|
Recruitment Status : Terminated
First Posted : December 21, 2005
Last Update Posted : May 7, 2007
|Condition or disease|
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.
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
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.
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||Retrospective Review of Hypertrophic Myopathy in Children|
|Study Start Date :||January 1996|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267462
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Kenneth J. Dooley, MD||Sibley Heart Center Cardiology at Children's Healthcare of Atlanta|