Comparison of Saphenous Vein Graft Harvested From Upper Versus Lower Leg in Coronary Artery Bypass Grafting (COSAVEGUL-1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Ki-Bong Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01974492
First received: October 26, 2013
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Triple Vessel Disease
Unstable Angina
Stable Angina
Myocardial Infarction
Procedure: Upper leg vein harvesting
Procedure: Lower leg vein harvesting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Histologic and Immunohistochemical Characteristics Between the Upper and Lower Leg Saphenous Veins Used for Coronary Artery Bypass Grafting

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Endothelial preservation of saphenous vein graft [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Participants will be followed for the duration of hospital stay, an expected average of 1 week.


Estimated Enrollment: 24
Study Start Date: October 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Upper leg vein
Upper leg vein harvesting
Procedure: Upper leg vein harvesting
Patients whose saphenous veins are harvested from upper legs.
Active Comparator: Lower leg vein
Lower leg vein harvesting
Procedure: Lower leg vein harvesting
Patients whose saphenous veins are harvested from lower legs.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974492

Contacts
Contact: Hyoung Woo Chang, M.D. +82-10-2709-5694 sspenser@chol.com
Contact: Ki-Bong Kim, M.D., Ph.D. +82-10-5326-3482 kimkb@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Ki-Bong Kim, M.D., Ph.D.    +82-10-5326-3482    kimkb@snu.ac.kr   
Principal Investigator: Ki-Bong Kim, M.D., Ph.D.         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Ki-Bong Kim, M.D., Ph.D. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Ki-Bong Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01974492     History of Changes
Other Study ID Numbers: SNUHTS_KBKim_Saphenous
Study First Received: October 26, 2013
Last Updated: November 4, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
saphenous vein graft
composite graft
coronary artery bypass grafting
graft remodeling

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Infarction
Myocardial Infarction
Angina, Stable
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 28, 2014