NCT02792075

Brief Summary

The purpose of this study is to evaluate the prognosis of coronary stenosis based on intracoronary Imaging.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
48mo left

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

15 active sites

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 Progress72%
Jul 2016Jun 2030

First Submitted

Initial submission to the registry

June 2, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

10.4 years

First QC Date

June 2, 2016

Last Update Submit

December 28, 2025

Conditions

Coronary Artery Disease

Keywords

Coronary StenosisIntracoronary ImagingVH-IVUSOCTNIRSgray scale IVUS

Outcome Measures

Primary Outcomes (1)

  • Target Vessel Failure

    defined as composite event of cardiac death, non-fatal myocardiac infarction, target vessel revascularization

    2 years

Secondary Outcomes (10)

  • All-cause death

    5 years

  • Cardiac death

    5 years

  • Number of myocardial infarction events

    5 years

  • Composite event of death or myocardial infarction

    5 years

  • Composite event of cardiac death or myocardial infarction

    5 years

  • +5 more secondary outcomes

Study Arms (4)

VH-IVUS

Patients with IVUS-derived virtual histology

Other: 5-year Follow-up

OCT

Patients with Optical coherence tomography

Other: 5-year Follow-up

NIRS

Patients with Near-infrared spectroscopy

Other: 5-year Follow-up

gray scale IVUS

Patients with gray-scale IVUS(Intravascular ultrasound)

Other: 5-year Follow-up

Interventions

5-year Follow-upOTHER
NIRSOCTVH-IVUSgray scale IVUS

Eligibility Criteria

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

Patients with intracoronary imaging

You may qualify if:

  • Patients with intracoronary imaging
  • Written consent

You may not qualify if:

  • Severe calcification and/or severe tortuosity
  • Lesion with previous bypass graft surgery (CABG)
  • Left ventricular ejection fraction less than 30 %
  • Coronary spasm
  • Life expectancy less than 2 years
  • Pregnancy or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

RECRUITING

Inje University Busan Paik Hospital

Busan, South Korea

RECRUITING

Soon Chun Hyang University Hospital Cheonan

Cheonan, South Korea

RECRUITING

Keimyung University Dongsan Medical Center

Daegu, South Korea

RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

Inje University Ilsan Paik Hospital

Ilsan, South Korea

RECRUITING

Gachon University Gil Hospital

Incheon, South Korea

TERMINATED

Jeju national university hospital

Jeju City, South Korea

RECRUITING

Pusan National University Hospital

Pusan, South Korea

RECRUITING

Chung-Ang university hospital

Seoul, South Korea

RECRUITING

Kangbuk Samsung Hospital

Seoul, South Korea

WITHDRAWN

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Ajou University Hospital

Suwon, South Korea

ACTIVE NOT RECRUITING

Ulsan University Hospital

Ulsan, South Korea

WITHDRAWN

Wonju Severance Christian Hospital

Wŏnju, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Seung-jung Park, MD

CONTACT

sjpark@amc.seoul.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor of medicine

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 7, 2016

Study Start

July 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2030

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

This is not a publicly funded trial.

Locations

KR(15)