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

NCT01974492 | Completed DMC

• 1 other identifier: SNUHTS_KBKim_Saphenous
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

saphenous vein graft; composite graft; coronary artery bypass grafting; graft remodeling

Outcome Measures

Primary Outcomes (1)

• Endothelial preservation of saphenous vein graft

  Participants will be followed for the duration of hospital stay, an expected average of 1 week.

  1 year

Study Arms (2)

Upper leg vein

ACTIVE COMPARATOR

Upper leg vein harvesting

Procedure: Upper leg vein harvesting

Lower leg vein

ACTIVE COMPARATOR

Lower leg vein harvesting

Procedure: Lower leg vein harvesting

Interventions

Upper leg vein harvesting PROCEDURE

Patients whose saphenous veins are harvested from upper legs.

Upper leg vein

Lower leg vein harvesting PROCEDURE

Patients whose saphenous veins are harvested from lower legs.

Lower leg vein

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Angina, Unstable; Angina, Stable; Myocardial Infarction

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Ki-Bong Kim, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2013
• First Posted: November 1, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2016
• Last Updated: July 4, 2016

Record last verified: 2016-06

Locations

KR (1)