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Ischemic Heart DiseaseNCT03870815

Long-term Outcomes and Prognostic Factors in Patient Undergoing CABG or PCI

An observational study of Ischemic Heart Disease, run by Samsung Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

1. To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease undergoing coronary artery bypass graft surgery. 2. To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease undergoing percutaneous coronary intervention… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Heart Disease
What is being tested?
CABG and PCI
Type of treatment
Surgery or procedure
How many people
10,000 participants
Where
1 siteSouth Korea
Study dates
27 Feb 2019to 28 Feb 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Age < 18 years

Trial locations and contacts

1 site in 1 country.

Young Bin Song, MD, PhD contact

82-2-3410-3419

youngbin.song@gmail.com

Ki Hong Choi, MD contact

82-10-8875-1648

cardiokh@gmail.com

South Korea1 site, 1 recruiting

  • Samsung Medical Center

    Seoul, 06351

    Young Bin Song, MD, PhD, 82-10-3410-3419, youngbin.song@gmail.com

    Ki Hong Choi, MD, 82-10-8875-1648, cardiokh@gmail.com

    Recruiting

Other trials in South Korea

About this study

Official title: Registry for Long-term Clinical Outcomes and Prognostic Factors in Patient With Coronary Artery Disease Undergoing Coronary Artery Bypass Graft Surgery or Percutaneous Coronary Intervention With Second Generation Drug-Eluting Stent

  1. To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease undergoing coronary artery bypass graft surgery.
  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.
Read the detailed description

Coronary artery disease (CAD) still remains one of the world's leading causes of death, despite markedly improvement of devices and technologies on past several decades. The treatment strategy for CAD included medical treatment, percutaneous coronary intervention (PCI), and coronary-artery bypass grafting (CABG). CABG is a procedure in which autologous arteries or veins are used as grafts to bypass coronary arteries that are partially or completely obstructed by atherosclerotic plaque. During the past decade, there has been nearly a 30% decline in CABG procedures, despite abundant evidence to support the effectiveness and safety of the operation.This decline has been accompanied by a corresponding increase in PCI. To date, there have been numerous studies to compare the clinical outcomes between PCI and CABG for patients with CAD. Among them, SYNTAX (Synergy between PCI with Taxus and Cardiac Surgery) trial demonstrated CABG is associated with lower incidence of major adverse cardiac and cerebrovascualr events in patients with high SYNTAX score, compared with PCI. In this regard, the current guidelines recommend that CABG is preferred method for care of stable ischemic heart disease patients with three-vessel or left main coronary artery disease. However, most randomized controlled studies do not reflect the contemporary practice, because they have been performed in the era of bare metal stents or first-generation drug-eluting stent (DES). In addition, there have been limited data regarding the prognostic factors for long-term clinical outcomes in patients undergoing PCI with DES or CABG. Therefore, the investigators sought to compare the clinical outcomes between PCI with DES or CABG, and to identify prognostic factors for long-term clinical outcomes in patients who underwent PCI with DES or CABG.

Being tested
CABG, PCI
Keywords
Ischemic heart disease, Coronary artery bypass grafting, Percutaneous coronary intervention
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CABGProcedure or surgery

    Patients who undergoing CABG

  • PCIProcedure or surgery

    Patients who undergoing PCI with DES

Study groups in NCT03870815
Study groupRoleWhat they receive
CABGPatients with CAD who undergoing CABG
Receives: Procedure: CABG
PCIPatients with CAD who undergoing PCI with DES
Receives: Procedure: PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiac Death

    death from cardiac-cause

    Measured: 5-Year after the index procedure

Secondary outcomes (7)

  1. All-cause Death

    death from any-cause

    Measured: 5-Year after the index procedure

  2. Myocardial infarction

    Myocardial infarction without peri-procedural myocardial infarction

    Measured: 5-Year after the index procedure

  3. Target-vessel revascularization

    ischemia-driven or all

    Measured: 5-Year after the index procedure

  4. Any revascularization

    ischemia-driven or all

    Measured: 5-Year after the index procedure

  5. Bleeding

    BARC type 2-5

    Measured: 5-Year after the index procedure

  6. Cerebrovascular accident

    Ischemic or hemorrhagic

    Measured: 5-Year after the index procedure

  7. MACCE (major adverse cardiac and cerebrovascular accident)

    a composite of death, myocardial infarction, and cerebrovascular accident

    Measured: 5-Year after the index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2019
  2. Study start27 Feb 2019
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion28 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03870815
Sponsor's protocol ID
CABG2019
Status last verified
Apr 2023
First submitted
10 Mar 2019
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gim DH, 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. Clinical Impact of Diabetes Mellitus After Intravascular Imaging-Guided PCI vs Coronary Artery Bypass Grafting. JACC Cardiovasc Interv. 2026 Mar 9;19(5):555-567. doi: 10.1016/j.jcin.2025.11.036.

    PubMed 41813275

  • 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.

    PubMed 40864021

  • 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.

    PubMed 39901632

  • 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.

    PubMed 39513369

  • 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.

    PubMed 39101114

  • 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.

    PubMed 38267144

  • 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.

    PubMed 36862681

  • 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.

    PubMed 36172577

  • 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.

    PubMed 33075126

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Heart Disease, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Young Bin Song, MD, PhD (82-2-3410-3419, youngbin.song@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac Death (time frame: 5-Year after the index procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03870815, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.

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