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Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) University of Maryland |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00481806 |
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.
Condition |
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Coronary Artery Bypass Thrombosis |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Thrombin Dysregulation Leads to Early Saphenous Vein Graft Failure |
Whole blood and vein samples
Estimated Enrollment: | 410 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | December 2011 |
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.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Male and female patients between the the age of 18-90 years belonging to all races will be enrolled in the study
Inclusion Criteria:
Exclusion Criteria:
Contact: Robert S. Poston, MD | 410-328-5842 ext 8469 | rposton@smail.umaryland.edu |
United States, Maryland | |
University of Maryland School of Medicine | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Principal Investigator: Robert S. Poston, MD |
Principal Investigator: | Robert S. Poston, MD | University of Maryland |
Responsible Party: | University of Maryland Medical Center ( Dr. Robert Poston, MD / Associate Professor of Surgery ) |
Study ID Numbers: | 479, R01 HL084080-01A1 |
Study First Received: | May 31, 2007 |
Last Updated: | December 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00481806 History of Changes |
Health Authority: | United States: Federal Government |
Virchow's Triad Thrombin Graft Failure |
Thrombin Embolism and Thrombosis Embolism |
Vascular Diseases Hemostatics Thrombosis |
Thrombin Embolism and Thrombosis Coagulants Therapeutic Uses Hematologic Agents |
Vascular Diseases Cardiovascular Diseases Pharmacologic Actions Hemostatics Thrombosis |