Using Tissue Doppler/Synchronization to Determine Heart Function in Children With Congenital Heart Disease
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|ClinicalTrials.gov Identifier: NCT00208676|
Recruitment Status : Terminated
First Posted : September 21, 2005
Last Update Posted : November 27, 2013
There are many children that have heart dysfunction because they are either born with Congenital Heart Disease (CHD) or developed poor heart function because their hearts are ill. The invention of medical technology helps in the treatment of these children. New heart echocardiogram (echo) techniques including Tissue Doppler (TDI), Tissue Synchronization Imaging (TSI) and 3 dimensional echocardiography (3D) are imaging technologies that we hope will help in the diagnosis and treatment of these children.
Tissue Doppler Imaging is a noninvasive technique that measures the speed of heart muscle movement. Tissue Synchronization Imaging measures how well the lower pumping chambers of the heart are working together. A 3D echo is a 3 dimensional picture of a beating heart that allows your doctor to see the heart from any angle. These techniques are noninvasive, meaning on the outside of your body. The size and function of the ventricles (the lower part of the heart) can change under different conditions. Using these techniques we will attempt to better determine how well the ventricles function during illness and health.
|Condition or disease|
|Congenital Heart Defects|
All subjects who are treated at Sibley Heart Center at Children's Healthcare of Atlanta with the diagnosis of a congenital heart defect or an acquired heart condition (i.e. heart failure) may be approached for possible participation into the study. These patients will include newly diagnosed patients as well as patients who were diagnosed in previous years and have received medical treatment for their defect or condition. The following describe study procedures:
Echocardiographic assessment Standard 2-dimensional, M-mode, and Doppler or 3-dimensional echocardiography evaluation will be performed. We will assess cardiac function using left ventricular shortening (SF) and ejection fractions (EF). The EF will be calculated using both M-Mode and by Simpson's rule. We will also perform tissue synchronization imaging (TSI) and tissue Doppler imaging (TDI) using the GE Vivid 7 echocardiographic system. Both TSI and TDI will assist investigators in assessing mechanical synchrony. The research echocardiograms will occur at the time of routine assessments.
Clinical assessment/data collection Clinical information from the chart will be collected for this study. The information will include the doctor's evaluation of general health, including diagnosis and the names of any medications the participant may be taking. If the child has undergone a routine MRI for the purpose of clinical care, the MRI measures will be collected in order to compare MRI images and measures to the new 3D echo technique. Finally, EKG data will be collected at each visit. EKGs are performed routinely for these patients however, if one is not performed, the study staff will perform an EKG assessment in order to have electromechanical information (i.e. arrhythmias) on all children participating.
|Study Type :||Observational|
|Enrollment :||200 participants|
|Official Title:||Non-Invasive Quantitation of Myocardial Dysfunction by Tissue Doppler / Synchronization Imaging in Children With Congenital Heart Defects (CHD)|
|Study Start Date :||September 2005|
|Study Completion Date :||January 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208676
|United States, Georgia|
|Children's Healthcare of Atlanta at Egleston|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Derek Fyfe, MD||Emory University|