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Current Treatment Strategy of Patients With Multivessel Disease or Left Main Coronary Artery Disease Indicated for Coronary Artery Bypass Graft Surgery

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ClinicalTrials.gov Identifier: NCT02410993
Recruitment Status : Unknown
Verified July 2018 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : April 8, 2015
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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.

Condition or disease Intervention/treatment
Coronary Artery Disease Procedure: CABG surgery

Study Design
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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : April 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients treated with PCI or medical treatment despite of recommendation for CABG surgery [ Time Frame: 1 month (After the revascularization strategy was finally decided) ]

Secondary Outcome Measures :
  1. Reason of ineligibility for CABG surgery [ Time Frame: 1 month (After the revascularization strategy was finally decided) ]
  2. the composite of major cardiac and cerebrovascular event (MACCE) [ Time Frame: 1 year follow up after revascularization ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital-based, full-service hospitals with capability of both PCI and CABG surgery in addition to cardiac catheterization
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410993


Contacts
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Contact: Myeong Ki Hong, MD, PhD 82-2-2228-8460 mkhong61@yuhs.ac

Locations
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Korea, Republic of
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: MYEONG-KI HONG, MD    82-2-2228-8458    MKHONG61@yuhs.ac   
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02410993    
Other Study ID Numbers: 4-2015-0063
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases