Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001632
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Investigation Into the Use of Ultrasound Technique in the Evaluation of Heart Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Myocardial Ultrasonic Tissue Characterization in Patients With a Genetic Predisposition for the Development of Hypertrophic Cardiomyopathy
Status:
COMPLETED
Status Verified Date:
2002-08
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 human heart is divided into four chambers One of the four chambers the left ventricle is the chamber mainly responsible for pumping blood out of the heart into the circulation Hypertrophic cardiomyopathy is a genetically inherited disease causing an abnormal thickening of heart muscle especially the muscle making up the left ventricle When the left ventricle becomes abnormally large it is called left ventricular hypertrophy LVH
Patients with HCM can be born with an enlarged left ventricle or they may develop the condition in childhood or adolescence usually during the time when the body is rapidly growing However not all patients with the abnormal genes linked to HCM have the characteristic LVH
Currently it is impossible to tell if a patient with the genes for HCM will develop LVH
A recently developed ultrasound tool called an integrated backscatter analysis IBS may allow researchers to determine those children who may later develop HCM and LVH In order to test this researchers plan to use IBS to study normal children with relatives diagnosed with HCM
This study will compare the results of IBS done on normal children with relatives diagnosed with HCM normal children and children with evidence enlarged heart muscle HCM
Patients with HCM can be born with an enlarged left ventricle or they may develop the condition in childhood or adolescence usually during the time when the body is rapidly growing However not all patients with the abnormal genes linked to HCM have the characteristic LVH
Currently it is impossible to tell if a patient with the genes for HCM will develop LVH
A recently developed ultrasound tool called an integrated backscatter analysis IBS may allow researchers to determine those children who may later develop HCM and LVH In order to test this researchers plan to use IBS to study normal children with relatives diagnosed with HCM
This study will compare the results of IBS done on normal children with relatives diagnosed with HCM normal children and children with evidence enlarged heart muscle HCM
Detailed Description:
Hypertrophic cardiomyopathy HCM is a genetically inherited disease that is characterized by unexplained left ventricular hypertrophy LVH often associated with diastolic dysfunction and myocardial ischemia In patients with HCM LVH may be present at birth or it may develop during childhood and adolescence usually during periods of rapid body growth Currently it is not possible to identify using clinical or laboratory methods those children who will develop LVH from among those with a genetic predisposition for the disease It would therefore be beneficial to find predictors of LVH development in normal children who have family history of HCM Integrated backscatter analysis IBS is a recently developed ultrasound tool that has been studied in patients with various cardiac diseases Integrated myocardial backscatter has been shown to vary throughout the cardiac cycle in normal subjects both pediatric and adult with peak values occurring during diastole and minimum values in end systole Several studies in both children and adults with HCM have shown a blunting of this variation in backscatter analysis We hypothesize that patients with a genetic predisposition for HCM but no echocardiographic evidence of the disease may have a greater prevalence of alterations in integrated myocardial backscatter when compared to children without a family history of HCM We therefore propose to examine the cyclic variation of integrated myocardial backscatter in children with a normal echocardiogram and a first-degree relative with HCM and compare it with the results obtained in a group of normal children as well as in a group of children with unequivocal echocardiographic evidence of HCM
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-H-0188 | None | None | None |