Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267462
Status:
TERMINATED
Last Update Posted:
2007-05-07
First Post:
2005-12-19
Brief Title:
Hypertrophic Myopathy in Children
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Retrospective Review of Hypertrophic Myopathy in Children
Status:
TERMINATED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The charts of children followed at Sibley Heart Center of Childrens 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 4251 4254 4257 4258 and 4259 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 005
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
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 005
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None