Evaluating the Role of Thrombin in Saphenous Vein Graft Failure After Heart Bypass Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00481806|
Recruitment Status : Unknown
Verified May 2013 by Robert Poston, University of Arizona.
Recruitment status was: Recruiting
First Posted : June 4, 2007
Last Update Posted : May 10, 2013
|Condition or disease|
|Coronary Artery Bypass Thrombosis|
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.
|Study Type :||Observational|
|Estimated Enrollment :||450 participants|
|Official Title:||Thrombin Dysregulation Leads to Early Saphenous Vein Graft Failure|
|Study Start Date :||February 2007|
|Estimated Primary Completion Date :||May 2013|
|Estimated Study Completion Date :||December 2013|
- Amplifying the severity of all three risk factors of Virchow's triad is expected to lead to a synergistic increase in regional thrombin formation [ Time Frame: Measured at 5 years ]
- Pressure distention is the main stimulus that creates a loss of thrombin control within the SVG [ Time Frame: Measured at 5 years ]
- Accurate tests of graft quality will be developed that provide rapid results for ready translation into clinical applications [ Time Frame: Measured at 5 years ]
- Aprotinin or bivalirudin will effectively suppress thrombin generation and its effects within the highest risk grafts [ Time Frame: Measured at 5 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481806
|Contact: Robert S. Poston, MDemail@example.com|
|United States, Arizona|
|University of Arizona College of Medicine||Recruiting|
|Tucson, Arizona, United States, 85724|
|Principal Investigator: Robert S. Poston, MD|
|Principal Investigator:||Robert S. Poston, MD||University of Arizona, Tucson|