NCT05124249

Brief Summary

To evaluate the long-term clinical outcomes and prognostic factors in patients with coronary artery disease (CAD) undergoing invasive coronary angiography (ICA), intravascular imaging, or invasive physiologic assessment.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Nov 2021

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 Progress50%
Nov 2021Dec 2030

Study Start

First participant enrolled

November 1, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 17, 2021

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

8.2 years

First QC Date

November 4, 2021

Last Update Submit

March 16, 2026

Conditions

Keywords

Percutaneous Coronary InterventionIntravascular ImagingIntravascular UltrasoundOptical Coherence TomographyFractional flow reserve

Outcome Measures

Primary Outcomes (1)

  • MACE

    a composite of all-cause death, myocardial infarction, or any revascularization

    3-Year after the index procedure

Secondary Outcomes (10)

  • Rate of all-cause death

    3-Year after the index procedure

  • Rate of cardiac death

    3-Year after the index procedure

  • Rate of myocardial infarction

    3-Year after the index procedure

  • Rate of target lesion revascularization

    3-Year after the index procedure

  • Rate of target vessel revascularization

    3-Year after the index procedure

  • +5 more secondary outcomes

Study Arms (2)

Invasive coronary angiography (ICA)

Patients who undergoing invasive coronary angiography with intravascular imaging or invasive physiologic assessment

Diagnostic Test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment

Percutaneous coronary intervention (PCI)

Patients who undergoing percutaneous coronary intervention with intravascular imaging or invasive physiologic assessment

Diagnostic Test: Intravascular imaging (IVUS or OCT) or Invasive physiologic assessmentProcedure: PCI

Interventions

Intravascular imaging (IVUS or OCT) or Invasive physiologic assessment

Invasive coronary angiography (ICA)Percutaneous coronary intervention (PCI)
PCIPROCEDURE

Patients who undergoing PCI

Percutaneous coronary intervention (PCI)

Eligibility Criteria

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

About 2,000 patients with suspected ischemic heart disease and underwent ICA, intravascular imaging, or invasive physiologic assessment

You may qualify if:

  • Subject must be at least 18 years of age
  • Subjects who suspected ischemic heart disease and underwent ICA.
  • Subjects who were performed intravascular imaging or invasive physiologic assessment

You may not qualify if:

  • Subject with Age \<18 years
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University Hospital

Gwangju, 61469, South Korea

RECRUITING

MeSH Terms

Conditions

Myocardial IschemiaAtherosclerosis

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Young Joon LeeHong, MD, PhD

    Chonnam National University Medical School; Chonnam National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Joon Hong, MD, PhD

CONTACT

Seung Hun Lee, MD, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

November 4, 2021

First Posted

November 17, 2021

Study Start

November 1, 2021

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
1 year after study completion

Locations