NCT05624905

Brief Summary

Coronary artery disease is the most important cause of death worldwide. Treatment option for coronary artery disease is medical treatment, percutaneous coronary intervention, or coronary artery bypass surgery. Among them, the field of percutaneous coronary intervention is rapidly developing with regard to the improvement of devices, techniques, or medical treatment, leading to reduce mortality or morbidity. Until now, numerous previous studies related to the risk factors of coronary artery disease and the prognosis of patients have been conducted. However, the field of percutaneous coronary intervention is rapidly evolving, and treatment strategies are constantly being updated. Therefore, the current study sought to identify the long-term prognosis and related risk factors of patients with coronary artery disease who underwent percutaneous coronary intervention.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Mar 2016

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 Progress69%
Mar 2016Dec 2030

Study Start

First participant enrolled

March 20, 2016

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 22, 2022

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

14.8 years

First QC Date

November 15, 2022

Last Update Submit

August 12, 2024

Conditions

Coronary Artery DiseasePercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (2)

  • Rates of Cardiac death or Target-vessel myocardial infarction

    A composite of cardiac death or target vessel myocardial infarction

    up to 10 years

  • Rates of Major adverse cardiac and cerebrovascular event

    A composite of all-cause death, myocardial infarction, cerebrovascular accident, or repeat revascularization

    up to 10 years

Secondary Outcomes (8)

  • Rates of all-cause death

    up to 10 years

  • Rates of cardiac death

    up to 10 years

  • Rates of myocardial infarction

    up to 10 years

  • Rates of target-vessel myocardial infarction

    up to 10 years

  • Rates of target lesion revascularization

    up to 10 years

  • +3 more secondary outcomes

Study Arms (1)

PCI group

All consecutive patients with coronary artery disease who underwent percutaneous coronary intervention

Procedure: Percutaneous coronary intervention

Interventions

Percutaneous coronary interventionPROCEDURE

Percutaneous Coronary Intervention Procedure

PCI group

Eligibility Criteria

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

All consecutive patients who underwent coronary angiography adn percutaneous coronary intervention

You may qualify if:

  • patients who have undergone or are scheduled to undergo coronary angiography and percutaneous coronary intervention.

You may not qualify if:

  • patients who did not consent to the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Related Publications (1)

  • Choi KH, Lee SY, Song YB, Park TK, Lee JM, Yang JH, Choi JH, Choi SH, Gwon HC, Hahn JY. Prognostic Impact of Operator Experience and IVUS Guidance on Long-Term Clinical Outcomes After Complex PCI. JACC Cardiovasc Interv. 2023 Jul 24;16(14):1746-1758. doi: 10.1016/j.jcin.2023.04.022.

    PMID: 37495350DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Joo-Yong Hahn, MD

CONTACT

82-2-3410-3419jyhahn@skku.edu

Ki Hong Choi, MD

CONTACT

82-2-3410-6653cardiokh@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 22, 2022

Study Start

March 20, 2016

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

August 14, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)