Evaluating the Role of Thrombin in Saphenous Vein Graft Failure After Heart Bypass Surgery

NCT ID: NCT00481806

Last Updated: 2013-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2013-12-31

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.

Conditions

Coronary Artery Bypass; Thrombosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore County

OTHER

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Robert Poston

Chief, Division of Cardiothoracic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert S. Poston, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona, Tucson

Locations

University of Arizona College of Medicine

Tucson, Arizona, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Robert S. Poston, MD

Role: CONTACT

rposton@surgery.arizona.edu

520-626-7951

References

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.

Reference Type: DERIVED

PMID: 21524447 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18936577 (View on PubMed)

Other Identifiers

R01HL084080-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

479

Identifier Type: -

Identifier Source: org_study_id