HealthyNCT00001632
Investigation Into the Use of Ultrasound Technique in the Evaluation of Heart Disease
An observational study of Healthy and Hypertrophic Cardiomyopathy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy, Hypertrophic Cardiomyopathy, Left Ventricular Hypertrophy
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1997to Aug 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria will be any historical or echocardiographic evidence of congenital or valvular heart disease or any form of cardiomyopathy.
- Exclusion criteria will be any evidence of congenital or valvular heart disease that may explain the presence of LVH.
- Exclusion criteria will be any historical or echocardiographic evidence of congenital or valvular heart disease or other form of cardiomyopathy.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Official title: Myocardial Ultrasonic Tissue Characterization in Patients With a Genetic Predisposition for the Development of Hypertrophic Cardiomyopathy
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.
Read more
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).
Read the 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.
- Keywords
- Hypertrophy, Integrated, Backscatter, Cyclic, Echocardiography, Hypertrophic Cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Hypertrophy, Left Ventricular, Hypertrophy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startSep 1997
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 195 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001632
- Sponsor's protocol ID
- 970188
- Other IDs
- 97-H-0188
- Status last verified
- Aug 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 2523641Miller 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.
PubMed 3898225Vitale 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.
PubMed 8941108
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Ultrasonic Tissue Characterization in Patients With a Genetic Predisposition for the Development of Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT00001632
- Acronym / sponsor ID
- 970188
- Keywords
- Hypertrophy, Integrated, Backscatter, Cyclic, Echocardiography, Hypertrophic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1997
- Study completion
- Aug 2002
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Normal children under the age of 15 who have a normal two-dimensional echocardiogram will be included in the study.
- Patients with HCM (unexplained LVH on two-dimensional echocardiogram) under the age of 15 will be included.
- Normal children under the age of 15 who have a first-degree relative with HCM and a normal two-dimensional echocardiogram will be included.
Key exclusion criteria (3 listed)
- Exclusion criteria will be any historical or echocardiographic evidence of congenital or valvular heart disease or any form of cardiomyopathy.
- Exclusion criteria will be any evidence of congenital or valvular heart disease that may explain the presence of LVH.
- Exclusion criteria will be any historical or echocardiographic evidence of congenital or valvular heart disease or other form of cardiomyopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 2523641Panza 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.
- Background: PubMed 3898225Miller 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.
- Background: PubMed 8941108Vitale 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Hypertrophic Cardiomyopathy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001632, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.