Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466804
Status:
COMPLETED
Last Update Posted:
2016-01-01
First Post:
2007-04-25
Brief Title:
Noninvasive Methods to Monitor Graft Survival in Heart Transplant Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Observational Study of Alloimmunity in Cardiac Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2015-12
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:
Injury of transplant tissue by a transplant recipients immune system continues to be the leading cause of graft rejection and recipient death The purpose of this study is to identify a single test or a combination of noninvasive tests currently used for heart transplant monitoring that correlate to long-term graft survival
Detailed Description:
A major cause of heart transplant failure is the blockage of blood flow from lesions caused by ongoing injury and repair of the graft by the hosts immune system However the role of T cells antibodies and other parts of the recipients immune system are not well understood in transplant injury Currently there are no effective noninvasive ways to detect or predict how an individuals immune system will react to a transplant The purpose of this study is to correlate current noninvasive monitoring tests with long-term graft survival and function and determine which tests are the most accurate predictors of this survival
Participants in this study must currently be on the waiting list for a heart transplant and have a donor heart available to them This study will consist of six study visits over 12 months The baseline visit will occur on the day of transplantation Follow-up visits will occur at Week 6 and Months 3 6 9 and 12 post-transplant At each visit a physical exam medication tracking assessment of graft survival and blood and urine collection will occur At the Week 6 and Month 12 visits intravascular ultrasound and echocardiograms will occur At the Week 6 Month 6 and Month 12 visits endomyocardial biopsies will also occur No immunosuppressive therapy will be provided by the study
Participants in this study must currently be on the waiting list for a heart transplant and have a donor heart available to them This study will consist of six study visits over 12 months The baseline visit will occur on the day of transplantation Follow-up visits will occur at Week 6 and Months 3 6 9 and 12 post-transplant At each visit a physical exam medication tracking assessment of graft survival and blood and urine collection will occur At the Week 6 and Month 12 visits intravascular ultrasound and echocardiograms will occur At the Week 6 Month 6 and Month 12 visits endomyocardial biopsies will also occur No immunosuppressive therapy will be provided by the study
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