NCT02410993

Brief Summary

According to 2011 ACCF/AHA guideline and 2014 ESC/EACTS guideline, CABG surgery was recommended for three-vessel coronary artery disease and left main coronary artery disease in the patients with stable ischemic heart disease as class I. 2-VD with proximal left anterior descending artery stenosis was also indicated for CABG surgery as class I recommendation. However, many patients have been recommended for PCI by catheterization laboratory cardiologist; 46% and 93% in the only-CABG candidates and both CABG and PCI candidates, retrospectively, defined by previous ACC/AHA guideline. Although the discordance between real practice in catheterization laboratory and guideline would be adjusted by recently updated guideline. The revascularization strategy for patients with 3-VD/LMD in real practice have been getting toward more PCI and less CABG surgery. In this study, we will identify the rate of CABG candidates who were treated with PCI or medical treatment instead of CABG surgery in different from current guideline. We are also going to compare two treatment strategies CABG surgery vs. PCI with 2nd generation DES regarding clinical outcomes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

4.9 years

First QC Date

April 3, 2015

Last Update Submit

July 15, 2018

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients treated with PCI or medical treatment despite of recommendation for CABG surgery

    1 month (After the revascularization strategy was finally decided)

Secondary Outcomes (2)

  • Reason of ineligibility for CABG surgery

    1 month (After the revascularization strategy was finally decided)

  • the composite of major cardiac and cerebrovascular event (MACCE)

    1 year follow up after revascularization

Study Arms (1)

CABG surgery

Candidates for CABG surgery for left main disease, three-vessel disease or two-vessel disease with proximal LAD stenosis indicated by current practice guideline

Procedure: CABG surgery

Interventions

CABG surgeryPROCEDURE
CABG surgery

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital-based, full-service hospitals with capability of both PCI and CABG surgery in addition to cardiac catheterization

You may qualify if:

  • Patients ≥ 19 years old
  • Left main disease, three-vessel disease or two-vessel disease with proximal LAD stenosis.

You may not qualify if:

  • Previous PCI within 1 year
  • Previous sternotomy
  • Primary PCI for STEMI
  • Contraindication or hypersensitivity to anti-platelet medications or contrast media
  • Planned need for concomitant other cardiac surgery (eg, valve surgery or resection of aortic or left ventricular aneurysm, etc)
  • Pregnant women or women with potential childbearing
  • Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
  • Inability to understand or read the informed content

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Myeong Ki Hong, MD, PhD

CONTACT

82-2-2228-8460mkhong61@yuhs.ac

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2015

First Posted

April 8, 2015

Study Start

April 1, 2015

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

July 17, 2018

Record last verified: 2018-07

Locations

KR(1)