Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481806
Status:
UNKNOWN
Last Update Posted:
2013-05-10
First Post:
2007-05-31
Brief Title:
Evaluating the Role of Thrombin in Saphenous Vein Graft Failure After Heart Bypass Surgery
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Thrombin Dysregulation Leads to Early Saphenous Vein Graft Failure
Status:
UNKNOWN
Status Verified Date:
2013-05
Last Known Status:
RECRUITING
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:
Heart bypass surgery also known as coronary artery bypass graft CABG surgery creates a detour around the blocked part of a heart artery to restore blood supply to the heart muscle The saphenous vein located along the inside of the leg is commonly used to create the bypass in a CABG surgery An abnormal increase in the blood clotting protein thrombin may cause the saphenous vein graft to close up and eventually fail This study will evaluate the relationship between thrombin levels and saphenous vein graft failures in people undergoing a CABG procedure
Detailed Description:
The saphenous vein which runs from the ankle to the groin along the inside of the leg is commonly used as a graft for people undergoing a CABG surgery The vein is removed from the leg and reattached to the heart to create a detour around the blocked part of a coronary artery Following this procedure many people are prescribed aspirin as a way to increase the chance that the graft procedure will be successful However saphenous vein graft failure may still occur in some people indicating a need to understand why this happens and who might be at risk for graft failure Thrombin a protein involved in the blood clotting process is somehow related to aspirin resistance abnormalities in blood flow and cell disruption within the saphenous vein all factors thought to increase the risk of graft failure The purpose of this study is to evaluate the likelihood that a burst in thrombin contributes to graft failure in people who have recently undergone a CABG procedure using the saphenous vein
This study will enroll individuals undergoing CABG surgery at the University of Maryland Prior to and immediately following surgery an incision will be made in the skin and the time required for the blood to form a clot will be determined During surgery participants blood vessels will be examined using imaging and cell analysis techniques Blood collection will occur before surgery immediately after surgery and on Days 1 3 and 30 following surgery A portion of blood will be frozen for future analysis An x-ray of the saphenous vein will be performed on Day 5 and again at a follow-up visit 6 to 12 months following surgery Kidney function will be measured at both of these visits prior to the x-ray procedure At the second visit health and mental status questionnaires will be completed
This study will enroll individuals undergoing CABG surgery at the University of Maryland Prior to and immediately following surgery an incision will be made in the skin and the time required for the blood to form a clot will be determined During surgery participants blood vessels will be examined using imaging and cell analysis techniques Blood collection will occur before surgery immediately after surgery and on Days 1 3 and 30 following surgery A portion of blood will be frozen for future analysis An x-ray of the saphenous vein will be performed on Day 5 and again at a follow-up visit 6 to 12 months following surgery Kidney function will be measured at both of these visits prior to the x-ray procedure At the second visit health and mental status questionnaires will be completed
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL084080-01A1 | NIH | None | httpsreporternihgovquickSearchR01HL084080-01A1 |