- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00481806
Evaluating the Role of Thrombin in Saphenous Vein Graft Failure After Heart Bypass Surgery
Thrombin Dysregulation Leads to Early Saphenous Vein Graft Failure
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Robert S. Poston, MD
- Phone Number: 520-626-7951
- Email: rposton@surgery.arizona.edu
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85724
- Recruiting
- University of Arizona College of Medicine
-
Principal Investigator:
- Robert S. Poston, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Scheduled for CABG surgery at University of Arizona University Medical Center (UMC)
- For females, willing to use a reliable form of birth control for the duration of the study
Exclusion Criteria:
- Non-dermatologic allergy to intravenous (IV) radiographic contrast
- Creatinine levels greater than 2.0 mg/dL
- Pregnant
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
Measured at 5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert S. Poston, MD, University of Arizona, Tucson
Publications and helpful links
General Publications
- Desai P, Kiani S, Thiruvanthan N, Henkin S, Kurian D, Ziu P, Brown A, Patel N, Poston R. Impact of the learning curve for endoscopic vein harvest on conduit quality and early graft patency. Ann Thorac Surg. 2011 May;91(5):1385-91; discussion 1391-2. doi: 10.1016/j.athoracsur.2011.01.079.
- Poston RS, Tran R, Collins M, Reynolds M, Connerney I, Reicher B, Zimrin D, Griffith BP, Bartlett ST. Comparison of economic and patient outcomes with minimally invasive versus traditional off-pump coronary artery bypass grafting techniques. Ann Surg. 2008 Oct;248(4):638-46. doi: 10.1097/SLA.0b013e31818a15b5.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 479
- R01HL084080-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Bypass
-
Nanjing First Hospital, Nanjing Medical UniversityCompletedCardiopulmonary Bypass | Coronary Artery Bypass GraftingChina
-
University of VirginiaNational Institute for Biomedical Imaging and Bioengineering (NIBIB)UnknownCoronary Artery BypassUnited States
-
University of MiamiNational Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Artery BypassUnited States
-
Imperial College LondonUnknownCoronary Artery BypassUnited Kingdom
-
Foundation University IslamabadActive, not recruitingCoronary Artery BypassPakistan
-
Medistim ASACompletedRegistry for Quality Assessment With Ultrasound Imaging and TTFM in Cardiac Bypass Surgery (REQUEST)Coronary Artery BypassUnited States, United Kingdom, Netherlands, Canada, Germany, Italy
-
Maastricht University Medical CenterDutch Health Care Insurance Board (nr: 00106), Amstelveen, The NetherlandsCompleted
-
Federal University of UberlandiaCompletedCoronary Artery Bypass
-
Yale UniversityGlenn Memorial FundRecruiting