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

Myocardial Infarction Clinical Trial

— COSAVEGUL-1  

Official title:

A Comparison of Histologic and Immunohistochemical Characteristics Between the Upper and Lower Leg Saphenous Veins Used for Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974492
• Other study ID #: SNUHTS_KBKim_Saphenous
• Status: Completed
• Phase: N/A
• First received: October 26, 2013
• Last updated: June 30, 2016
• Start date: October 2013
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Stable
• Angina, Unstable
• Myocardial Infarction
• Stable Angina
• Triple Vessel Disease
• Unstable Angina

Intervention

Procedure:
• Upper leg vein harvesting
Patients whose saphenous veins are harvested from upper legs.
• Lower leg vein harvesting
Patients whose saphenous veins are harvested from lower legs.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial preservation of saphenous vein graft	Participants will be followed for the duration of hospital stay, an expected average of 1 week.	1 year	No