Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208650
Status:
COMPLETED
Last Update Posted:
2013-11-27
First Post:
2005-09-13
Brief Title:
Tissue Doppler Echo Imaging of Heart Function After Transplant
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Non-Invasive Quantitation of Myocardial Dysfunction by Tissue DopplerSynchronization Imaging After Orthotopic Heart Transplantation in Children
Status:
COMPLETED
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 born with Congenital Heart Disease Many of these children have to undergo surgical procedures to correct the problem Some patients must eventually get a new heart Once they get a new heart we have to have ways to determine how well the new heart is doing inside of the body Tissue Doppler Imaging is one way of doing so Tissue Doppler Imaging is like an ultrasounds It takes pictures of the heart In addition to Tissue Doppler Imaging there is a newer non-invasive procedure called Tissue Synchronization Imaging which will allow us to see how well the new heart is working as well In this study we would use both techniques to determine how well the new heart is working
Detailed Description:
Heart transplantation is the only hope for children with end stage heart disease Eventually cardiac deterioration occurs and leads to death or re-transplantation Our understanding of the pathophysiology of cardiac dysfunction in these children is incomplete The time course of the dysfunction process either in the RV andor the LV systole or diastole has never been studied in children No meaningful TSI quantitation has ever been performed in a large pediatric OHT patient population The long-term goal of this study will be the detection of functional myocardial changes associated with known stages post heart transplantation using TDI and TSI These achievements impact the survival and quality of life of children after cardiac transplantation
Research Design and Methods
All subjects who are treated in the transplant clinic will be approached for possible participation into the study These patients will include newly transplanted OHT patients as well as patients who underwent OHT prior to the enrollment year The following procedures will occur at each study visit
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 In newly transplanted patients these echocardiographic assessments will occur during the first 5 days to serially measure ventricular synchrony during the acute post-operative period For older transplant patients and for new transplant patients greater than five days out from transplantation echocardiographic studies will occur at all follow-up clinic visits as determined by physician preference
Clinical assessment Clinical evaluation will be performed during all follow-up visits in order to track unrecognized complications or adverse events As is standard all patients undergoing transplantation follow-up will have an electrocardiogram EKG performed to assess rhythm
Research Design and Methods
All subjects who are treated in the transplant clinic will be approached for possible participation into the study These patients will include newly transplanted OHT patients as well as patients who underwent OHT prior to the enrollment year The following procedures will occur at each study visit
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 In newly transplanted patients these echocardiographic assessments will occur during the first 5 days to serially measure ventricular synchrony during the acute post-operative period For older transplant patients and for new transplant patients greater than five days out from transplantation echocardiographic studies will occur at all follow-up clinic visits as determined by physician preference
Clinical assessment Clinical evaluation will be performed during all follow-up visits in order to track unrecognized complications or adverse events As is standard all patients undergoing transplantation follow-up will have an electrocardiogram EKG performed to assess rhythm
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