Comparison of Saphenous Vein Graft Harvested From Upper Versus Lower Leg in Coronary Artery Bypass Grafting

NCT ID: NCT01974492

Last Updated: 2016-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-06-30

Brief Summary

In coronary artery bypass grafting, saphenous veins are widely used as a composite grafts that are Y-anastomosed to in-situ left internal thoracic artery. Based on our observation that remodeling of saphenous vein graft differs between those harvested from upper leg vein and lower leg, this study aims to compare histologic and immunohistochemical findings between saphenous vein grafts harvested from upper leg and lower leg.

Detailed Description

Inclusion criteria:

• Patients aged from 40 to 75 years with triple vessel disease
• Patients who are eligible for the use of left internal thoracic artery as an in situ primary conduit
• Operation plan: saphenous vein graft will be Y-anastomosed to left internal thoracic artery.
• Patients whose saphenous vein grafts can be harvested from both upper legs and lower legs
• Patients who are eligible for off-pump coronary artery bypass grafting
• Patients who agreed with the participation in the research based on thorough explanation.

Patients will be randomly assigned to upper leg vein (ULV) group and lower leg vein (LLV) group immediately after anesthetic induction.

Pieces of residual saphenous vein graft will be sent for histologic and immunohistochemical examination for the evaluation of endothelial cell preservation and the expression of matrix proteins.

Conditions

Triple Vessel Disease; Unstable Angina; Stable Angina; Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Upper leg vein

Upper leg vein harvesting

Group Type: ACTIVE_COMPARATOR

Upper leg vein harvesting

Intervention Type: PROCEDURE

Patients whose saphenous veins are harvested from upper legs.

Lower leg vein

Lower leg vein harvesting

Group Type: ACTIVE_COMPARATOR

Lower leg vein harvesting

Intervention Type: PROCEDURE

Patients whose saphenous veins are harvested from lower legs.

Interventions

Upper leg vein harvesting

Patients whose saphenous veins are harvested from upper legs.

Intervention Type: PROCEDURE

Lower leg vein harvesting

Patients whose saphenous veins are harvested from lower legs.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with multivessel disease who were planned to undergo off-pump coronary artery bypass grafting
• Patients whose left internal thoracic arteries can be used, and whose saphenous vein grafts will be Y-anastomosed to left internal thoracic arteries.
• Patients whose saphenous vein grafts can be harvested from both upper and lower legs.

Exclusion Criteria

• Patients with overt heart failure symptoms
• Patients with intractable ventricular arrhythmia
• Patients with history of cancer or malignancy
• Patients with coagulation or other hematologic disorder
• Patients who needs concomitant cardiac procedures

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ki-Bong Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ki-Bong Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SNUHTS_KBKim_Saphenous

Identifier Type: -

Identifier Source: org_study_id