Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208676
Status:
TERMINATED
Last Update Posted:
2013-11-27
First Post:
2005-09-13
Brief Title:
Using Tissue DopplerSynchronization to Determine Heart Function in Children With Congenital Heart Disease
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Non-Invasive Quantitation of Myocardial Dysfunction by Tissue Doppler Synchronization Imaging in Children With Congenital Heart Defects CHD
Status:
TERMINATED
Status Verified Date:
2013-11
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:
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
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
Detailed Description:
All subjects who are treated at Sibley Heart Center at Childrens Healthcare of Atlanta with the diagnosis of a congenital heart defect or an acquired heart condition ie 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 Simpsons 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 assessmentdata collection Clinical information from the chart will be collected for this study The information will include the doctors 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 ie arrhythmias on all children participating
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 Simpsons 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 assessmentdata collection Clinical information from the chart will be collected for this study The information will include the doctors 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 ie arrhythmias on all children participating
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