Investigation Into the Use of Ultrasound Technique in the Evaluation of Heart Disease
Myocardial Ultrasonic Tissue Characterization in Patients With a Genetic Predisposition for the Development of Hypertrophic Cardiomyopathy
2 other identifiers
observational
195
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 1997
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 3, 1999
CompletedFirst Posted
Study publicly available on registry
November 4, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2002
CompletedMarch 4, 2008
August 1, 2002
November 3, 1999
March 3, 2008
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Three groups of subjects (aged 1-15 years) will be studied: normal children, children with HCM, and children that are family members of patients with HCM, but do not themselves have any evidence of LVH.
- CONTROL GROUP (NORM GROUP):
- Normal children under the age of 15 who have a normal two-dimensional echocardiogram will be included in the study.
- HYPERTROPHIC CARDIOMYOPATHY GROUP (HCM GROUP):
- Patients with HCM (unexplained LVH on two-dimensional echocardiogram) under the age of 15 will be included.
- Family History of Hypertrophic Cardiomyopathy Group (FHCM GROUP:
- Normal children under the age of 15 who have a first-degree relative with HCM and a normal two-dimensional echocardiogram will be included.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892, United States
Related Publications (3)
Panza JA, Maron BJ. Relation of electrocardiographic abnormalities to evolving left ventricular hypertrophy in hypertrophic cardiomyopathy during childhood. Am J Cardiol. 1989 May 15;63(17):1258-65. doi: 10.1016/0002-9149(89)90187-2.
PMID: 2523641BACKGROUNDMiller JG, Perez JE, Sobel BE. Ultrasonic characterization of myocardium. Prog Cardiovasc Dis. 1985 Sep-Oct;28(2):85-110. doi: 10.1016/0033-0620(85)90020-9. No abstract available.
PMID: 3898225BACKGROUNDVitale DF, Bonow RO, Calabro R, De Cristofaro M, Pacileo G, Caso P, Gerundo G, Bordini C, Losi MA, Rengo C, Rengo F. Myocardial ultrasonic tissue characterization in pediatric and adult patients with hypertrophic cardiomyopathy. Circulation. 1996 Dec 1;94(11):2826-30. doi: 10.1161/01.cir.94.11.2826.
PMID: 8941108BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 3, 1999
First Posted
November 4, 1999
Study Start
September 1, 1997
Study Completion
August 1, 2002
Last Updated
March 4, 2008
Record last verified: 2002-08