Prognosis of Coronary Stenosis Based on Intracoronary Imaging; A Multicenter, Prospective Observational Study (IRIS imaging)

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: 5-year Follow-up

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Recruiting
    • Inje University Busan Paik Hospital
    • Contact: Tae-hyun Yang, MD
    • Principal Investigator: Tae-hyun Yang, MD
  • Cheonan, Korea, Republic of
    • Recruiting
    • Soon Chun Hyang University Hospital Cheonan
    • Contact: Seung-jin Lee, MD
    • Principal Investigator: Seung-jin Lee, MD
  • Daegu, Korea, Republic of
    • Recruiting
    • Keimyung University Dongsan Medical Center
    • Principal Investigator: Seung-Ho Huh, MD
    • Contact: Seung-Ho Huh, MD
  • Daejeon, Korea, Republic of
    • Recruiting
    • Chungnam National University Hospital
    • Contact: Jin-ok Jeong, MD
    • Principal Investigator: Jin-ok Jeong, MD
  • Ilsan, Korea, Republic of
    • Recruiting
    • Inje University Ilsan Paik Hospital
    • Contact: Sung-yun Lee, MD
    • Principal Investigator: Sung-yun Lee, MD
  • Incheon, Korea, Republic of
    • Terminated
    • Gachon University Gil Hospital
  • Jeju, Korea, Republic of
    • Recruiting
    • Jeju National University Hospital
    • Contact: Song-yi Kim, MD
    • Principal Investigator: Song-yi Kim, MD
  • Pusan, Korea, Republic of
    • Recruiting
    • Pusan National University Hospital
    • Contact: Jun-hyuck Oh, MD
    • Principal Investigator: Jun-hyuck Oh, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Guro Hospital
    • Contact: SEUNG-UN NA, MD
    • Principal Investigator: SEUNG-UN NA, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Chung-Ang University Hospital
    • Contact: Sang-wook Kim, MD
    • Principal Investigator: Sang-wook Kim, MD
  • Seoul, Korea, Republic of
    • Withdrawn
    • Kangbuk Samsung Hospital
  • Suwon, Korea, Republic of
    • Active, not recruiting
    • Ajou University Hospital
  • Ulsan, Korea, Republic of
    • Withdrawn
    • Ulsan University Hospital
  • Wonju, Korea, Republic of
    • Recruiting
    • Wonju Severance Christian Hospital
    • Contact: Jung-han Yoon, MD
    • Principal Investigator: Jung-han Yoon, MD
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 138-736
      • Recruiting
      • Asan Medical Center
      • Contact: Seung-jung Park, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with intracoronary imaging

Description

Inclusion Criteria:

• Patients with intracoronary imaging
• Written consent

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Vessel Failure	defined as composite event of cardiac death, non-fatal myocardiac infarction, target vessel revascularization	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death		5 years
All-cause death		5 years
Number of myocardial infarction events	Q wave myocardial infarction or non Q wave myocardial infarction	5 years
Composite event of death or myocardial infarction		5 years
Composite event of cardiac death or myocardial infarction		5 years
Target Vessel revascularization		5 years
Target Lesion revascularization		5 years
Number of stent thrombosis events	DEFINITE stent thrombosis : acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE stent thrombosis : unexplained death within 30 days or target-vessel infarction without angiographic information Academic Research Consortium (ARC) stent thrombosis is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute stent thrombosis: 0-24 hours after stent implantation; Subacute stent thrombosis: >24 hours to 30 days post; late stent thrombosis: >30 days to 1 year post; Very late stent thrombosis: >1 year post;	5 years
Number of stroke		5 years
Procedural success	Defined as mean lesion diameter stenosis less than 30% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death	7 days

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): June 1, 2029

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimate): June 7, 2016

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: OCT; Coronary Stenosis; NIRS; Intracoronary Imaging; VH-IVUS; gray scale IVUS
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Coronary Disease; Coronary Artery Disease; Constriction, Pathologic; Coronary Stenosis
• Other Study ID Numbers: AMCCV2016-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is not a publicly funded trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No