NCT03870815

Brief Summary

  1. 1.To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease undergoing coronary artery bypass graft surgery.
  2. 2.To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease undergoing percutaneous coronary intervention with drug-eluting stent.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 27, 2019

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

6.8 years

First QC Date

March 10, 2019

Last Update Submit

April 10, 2023

Conditions

Ischemic Heart Disease

Keywords

Ischemic heart diseaseCoronary artery bypass graftingPercutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

  • Cardiac Death

    death from cardiac-cause

    5-Year after the index procedure

Secondary Outcomes (7)

  • All-cause Death

    5-Year after the index procedure

  • Myocardial infarction

    5-Year after the index procedure

  • Target-vessel revascularization

    5-Year after the index procedure

  • Any revascularization

    5-Year after the index procedure

  • Bleeding

    5-Year after the index procedure

  • +2 more secondary outcomes

Study Arms (2)

CABG

Patients with CAD who undergoing CABG

Procedure: CABG

PCI

Patients with CAD who undergoing PCI with DES

Procedure: PCI

Interventions

CABGPROCEDURE

Patients who undergoing CABG

CABG
PCIPROCEDURE

Patients who undergoing PCI with DES

PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

About 10,000 patients with suspected ischemic heart disease and who underwent PCI with DES or CABG.

You may qualify if:

  • Patients who suspected ischemic heart disease and underwent CABG or PCI with DES

You may not qualify if:

  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Related Publications (8)

  • Lee SY, Cho YH, Sung K, Kim WS, Lee SJ, Kwon W, Lee JY, Lee SH, Shin D, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Choi KH, Park TK, Yang JH, Choi SH, Gwon HC, Song YB, Hahn JY, Jeong DS, Lee JM. Intravascular Imaging-Guided PCI vs Coronary Artery Bypass Grafting for Left Main or 3-Vessel Disease. JACC Cardiovasc Interv. 2025 Sep 8;18(17):2077-2088. doi: 10.1016/j.jcin.2025.06.034. Epub 2025 Aug 27.

    PMID: 40864021DERIVED

  • Lee SY, Lee SJ, Kwon W, Lee SH, Shin D, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Choi KH, Park TK, Yang JH, Choi SH, Gwon HC, Song YB, Hahn JY, Lee JY, Lee JM, Investigators TR. Outcomes of intravascular imaging-guided percutaneous coronary intervention according to lesion complexity. EuroIntervention. 2025 Feb 3;21(3):e171-e182. doi: 10.4244/EIJ-D-24-00755.

    PMID: 39901632DERIVED

  • Lee SH, Jo J, Yang JH, Kim SM, Choi KH, Song YB, Jeong DS, Lee JM, Park TK, Hahn JY, Choi SH, Chung SR, Cho YH, Sung K, Kim WS, Gwon HC, Lee YT. Clinical Impact of Sarcopenia Screening on Long-Term Mortality in Patients Undergoing Coronary Bypass Grafting. J Cachexia Sarcopenia Muscle. 2024 Dec;15(6):2842-2851. doi: 10.1002/jcsm.13645. Epub 2024 Nov 8.

    PMID: 39513369DERIVED

  • Joh HS, Kwon W, Shin D, Lee SH, Hong YJ, Hong D, Lee SY, Park H, Kim S, Lee SY, Koh JS, Kim H, Kim CJ, Choo EH, Yoon HJ, Park SD, Jeon KH, Bae JW, Ahn SG, Kim SE, Choi KH, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee JM. Drug-Coated Balloon Angioplasty in Patients Undergoing Complex Percutaneous Coronary Intervention. JACC Asia. 2024 Jun 18;4(7):519-531. doi: 10.1016/j.jacasi.2024.04.007. eCollection 2024 Jul.

    PMID: 39101114DERIVED

  • Kwon W, Hong D, Choi KH, Lee SH, Shin D, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Park TK, Yang JH, Choi SH, Gwon HC, Song YB, Hahn JY, Lee JM; RENOVATE-COMPLEX-PCI Investigators. Intravascular Imaging-Guided Percutaneous Coronary Intervention Before and After Standardized Optimization Protocols. JACC Cardiovasc Interv. 2024 Jan 22;17(2):292-303. doi: 10.1016/j.jcin.2023.10.062.

    PMID: 38267144DERIVED

  • Jang WJ, Choi KH, Kim J, Yang JH, Hahn JY, Choi SH, Gwon HC, Cho YH, Sung K, Kim WS, Jeong DS, Song YB. Impact of gender on mid-term prognosis of patients undergoing coronary artery bypass grafting. PLoS One. 2023 Mar 2;18(3):e0279030. doi: 10.1371/journal.pone.0279030. eCollection 2023.

    PMID: 36862681DERIVED

  • Kwon W, Choi KH, Jeong DS, Lee SY, Lee JM, Park TK, Yang JH, Hahn JY, Choi SH, Chung SR, Cho YH, Sung K, Kim WS, Gwon HC, Lee YT, Song YB. Comparison of long-term cardiovascular and renal outcomes between percutaneous coronary intervention and coronary artery bypass grafting in multi-vessel disease with chronic kidney disease. Front Cardiovasc Med. 2022 Sep 12;9:951113. doi: 10.3389/fcvm.2022.951113. eCollection 2022.

    PMID: 36172577DERIVED

  • Choi KH, Song YB, Jeong DS, Jang YH, Hong D, Lee SY, Youn T, Bak M, Min KM, Lee JM, Park TK, Yang JH, Hahn JY, Choi JH, Choi SH, Chung SR, Cho YH, Sung K, Kim WS, Gwon HC, Lee YT. Differential effects of dual antiplatelet therapy in patients presented with acute coronary syndrome vs. stable ischaemic heart disease after coronary artery bypass grafting. Eur Heart J Cardiovasc Pharmacother. 2021 Nov 3;7(6):517-526. doi: 10.1093/ehjcvp/pvaa080.

    PMID: 33075126DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Young Bin Song, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Bin Song, MD, PhD

CONTACT

82-2-3410-3419youngbin.song@gmail.com

Ki Hong Choi, MD

CONTACT

82-10-8875-1648cardiokh@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 10, 2019

First Posted

March 12, 2019

Study Start

February 27, 2019

Primary Completion

December 31, 2025

Study Completion

February 28, 2026

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

KR(1)