Graft Patency Analysis of the Right Coronary Artery System

This study has been terminated.
(Poor recruiting rate)
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01559350
First received: March 19, 2012
Last updated: April 13, 2016
Last verified: March 2012
  Purpose

The ideal grafts for the right coronary artery system in coronary artery bypass surgery remain controversial. The objective of this study is to compare the long-term patency of a right gastroepiploic artery and a saphenous vein graft used for revascularization of the right coronary artery system in off pump coronary artery bypass surgery and to analyze the long-term clinical outcomes.

Total 224 patients will be enrolled according to the randomization protocol.

Check list

  1. Laboratories
  2. Quantitative coronary analysis (preoperative)
  3. Major adverse cardiac and cerebrovascular event
  4. coronary CT (coronary angiography if needed) at discharge, 1, 5, 10 years postoperatively
  5. Echocardiogram

5. Cardiac enzyme


Condition Intervention
Coronary Artery Disease
Procedure: A right gastroepiploic artery in situ grafting
Procedure: A saphenous vein grafting

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Graft Patency of the Right Coronary Artery System in OPCAB: Saphenous Vein Graft Versus Right Gastroepiploic Artery

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Graft occlusion [ Time Frame: one year ] [ Designated as safety issue: No ]
    Coronary CT follow up at discharge, 1, 5 and 10 years postoperatively


Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: December 2022
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
RGEA group
A right gastroepiploic artery in situ grafting in the right coronary artery system during OPCAB
Procedure: A right gastroepiploic artery in situ grafting
A right gastroepiploic artery in situ grafting in the right coronary artery system during OPCAB
SVG group
A saphenous vein grafting in the right coronary artery system during OPCAB
Procedure: A saphenous vein grafting
A saphenous vein grafting in the right coronary artery system during OPCAB

Detailed Description:
The ideal bypass conduit for the right coronary artery remains a subject of intense controversy. A variety of grafts and configurations are used: the right gastroepiploic artery,the right internal thoracic artery in situ or in a Y-graft configuration,the free radial artery implanted into the aorta or the left internal thoracic artery, and the saphenous vein graft. The influence of the type of graft to the right coronary artery system on clinical results remains poorly documented, and the complementary conduit of choice to this system has yet to be determined. No superior long-term patency rate for any of these grafts to the RCA has been clearly established. We have used a saphenous vein and a right gastroepiploic artery for the right coronary artery system.
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who undergo OPCAB for triple vessel disease at Samsung Medical Center are enrolled.
Criteria

Inclusion Criteria:

  • Angiographic evidence of severe coronary stenosis on the right coronary territory
  • Elective surgery
  • Isolated off pump CABG
  • Age < 75 years and life expectancy > 5 years
  • Preoperative RGEA diameter > 1.5mm
  • Normal left ventricular function

Exclusion Criteria:

  • History of upper abdomen surgery
  • History of upper GI bleeding
  • Active gastric or duodenal ulcer
  • Body mass index > 35kg/m2
  • Redo surgery
  • Presence of varicose vein
  • Contraindication for CABG such as malignancy or liver cirrhosis
  • Other configuration than RGEA to RCA territory or SVG to RCA territory
  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: NCT01559350

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Study Director: Young Tak Lee, MD, PhD Samsung Medical Center
  More Information

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01559350     History of Changes
Other Study ID Numbers: 2011-11-065 
Study First Received: March 19, 2012
Last Updated: April 13, 2016
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
OPCAB

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 26, 2016