Thrombosis Clinical Trial
Official title:
Thrombin Dysregulation Leads to Early Saphenous Vein Graft Failure
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.
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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