Long-term Outcomes and Prognostic Factors in Patient Unde... | NCT03870815

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

NCT03870815

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Apr 12, 2023Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Ischemic Heart Disease

Interventions

CABG
PCI

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 27, 2019Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Feb 28, 2026Estimated

First Submitted Date

Mar 10, 2019

First Submission Date that Met QC Criteria

Mar 10, 2019

First Posted Date

Mar 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2023

Last Update Posted Date

Apr 12, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Young Bin Song, Associate Professor, Samsung Medical CenterPrincipal Investigator

Lead Sponsor

Samsung Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CABG		Patients with CAD who undergoing CABG	Procedure: CABG
PCI		Patients with CAD who undergoing PCI with DES	Procedure: PCI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CABG	Procedure	Patients who undergoing CABG	CABG
PCI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiac Death	death from cardiac-cause	5-Year after the index procedure

Secondary Outcomes

Measure	Description	Time Frame
All-cause Death	death from any-cause	5-Year after the index procedure
Myocardial infarction	Myocardial infarction without peri-procedural myocardial infarction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Age < 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Young Bin Song, MD, PhD	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul		06351	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41813275	Derived	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.
40864021

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases