Observational Study for Left Main Disease Treatment (IRIS-MAIN)

A GLOBAL, MULTICENTER, PROSPECTIVE, REAL WORLD OBSERVATIONAL STUDY FOR LEFT MAIN DISEASE TREATMENT

The purpose of this study is to observe clinical courses for long-term in patients with unprotected LMCA disease and to evaluate comparative results of medical treatment, coronary stenting with drug-eluting stents, and CABG for the treatment of an unprotected LMCA stenosis in the "real world" daily practice.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease

Detailed Description

This study is a multicenter, large clinical registry to evaluate comparative outcomes of medical therapy, PCI with DES, or CABG for patients with unprotected LMCA stenosis in the Asia-Pacific, as recorded in the MAIN-IRIS Registry. Data will be prospectively collected on approximately 5000 subjects who diagnosed LM disease (>50% by visual estimation) at approximately 65 centers in Korea and Asia-Pacific region. Brief study design is as depicted in the following figure

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Seung-Jung Park, MD, PhD; Phone Number: 82-2-3010-3152; Email: sjpark@amc.seoul.kr

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • ZhongShan Hospital
• Korea, Republic of
  • Anyang, Korea, Republic of
    • Recruiting
    • Hallym University Medical Center
    • Contact: Woo-jung Park, MD
    • Principal Investigator: woo-jung Park, MD
  • Bucheon, Korea, Republic of
    • Terminated
    • Soonchunhyang University Hospital, Buchen
  • Bucheon, Korea, Republic of
    • Terminated
    • The Catholic University of Korea, Bucheon St.Mary's Hospital
  • 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
    • Soonchunhyang University Hospital, Cheonan
    • Contact: Won Yong Shin
  • Cheongju, Korea, Republic of
    • Terminated
    • St.Mary's Catholic Medical Center
  • Daegu, Korea, Republic of
    • Recruiting
    • Keimyung University Dongsan Medical Center
    • Contact: Seung-ho Hur, MD
    • Principal Investigator: Seung-ho Hur, MD
  • Daegu, Korea, Republic of
    • Recruiting
    • Daegu Catholic University Medical Center
    • Contact: Kee-Sik Kim, MD
    • Principal Investigator: Kee-Sik Kim, MD
  • Daegu, Korea, Republic of
    • Terminated
    • Yeungnam University Medical Center
  • Daejeon, Korea, Republic of
    • Recruiting
    • Chungnam National University Hospital
    • Contact: Jin-ok Jeong, MD
    • Principal Investigator: Jin-ok Jeong, MD
  • Daejeon, Korea, Republic of
    • Terminated
    • The Catholic University of Korea, Daejeon ST.Mary's Hospital
  • Gangneung, Korea, Republic of
    • Recruiting
    • Gangneung Asan Medical Center
    • Contact: Sang-Sig Cheong, MD
    • Principal Investigator: Sang-Sig Cheong, MD
  • Gwangju, Korea, Republic of
    • Recruiting
    • Chonnam National University Hospital
    • Contact: Myung-ho Jeong, MD
    • Principal Investigator: Myung-ho Jeong, MD
  • Ilsan, Korea, Republic of
    • Terminated
    • National Health Insurance Service Ilsan Hospital
  • Inchon, Korea, Republic of
    • Terminated
    • St.Mary's Catholic Medical Center
  • Jeonju, Korea, Republic of
    • Recruiting
    • Chonbuk National University Hospital
    • Contact: Jei-keon Chae, MD
  • Jeonju, Korea, Republic of
    • Recruiting
    • Presbyterian Medical Center
    • Contact: Jay-young Rhew, MD
    • Principal Investigator: Jay-young Rhew, MD
  • Kwangju, Korea, Republic of
    • Recruiting
    • Kwangju Christian Hospital
  • Pusan, Korea, Republic of
    • Recruiting
    • Pusan Natioanal University Hospital
    • Contact: June-Hong Kim, MD, PhD
    • Principal Investigator: June-Hong Kim, MD, PhD
  • Seongnam, Korea, Republic of
    • Terminated
    • Bundang CHA Hospital
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Hyo-Soo Kim, MD, PhD
  • Seoul, Korea, Republic of
    • Recruiting
    • Gangnam Severance Hospital
    • Contact: Hyuck-Moon Kwon, MD
    • Principal Investigator: Hyuck-moon Kwon, MD
  • Seoul, Korea, Republic of, 138-736
    • Recruiting
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Anam Hospital
    • Contact: Do-sun Lim, MD
    • Principal Investigator: Do-sun Lim, 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
    • Dongguk University Medical Center
    • Contact: Deuk-young Nah, MD
    • Principal Investigator: Deuk-young Nah, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Kangbuk Samsung Hospital
    • Contact: Byung-jin Kim, MD
    • Principal Investigator: Byung-jin Kim, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Kangdong Sacred Heart Hospital
    • Contact: Kyoo-rok Han, MD
    • Principal Investigator: Kyoo-rok Han, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Boramae Medical Center
    • Contact: Woo-young Chung, MD
    • Principal Investigator: Woo-young Chung, MD
  • Seoul, Korea, Republic of
    • Terminated
    • Seoul Veterans Hospital
  • Seoul, Korea, Republic of
    • Terminated
    • The Catholic University of Korea, St. Paul's hospital
  • Seoul, Korea, Republic of
    • Terminated
    • The Catholic University of Korea, Yeouido St. Mary's Hospital
  • Seoul, Korea, Republic of
    • Terminated
    • Yonsei University Medical Center
  • Seoul, Korea, Republic of
    • Terminated
    • St.Mary's Catholic Medical Center
  • Suwon, Korea, Republic of
    • Terminated
    • Ajou University Hospital
  • Suwon, Korea, Republic of
    • Recruiting
    • The Catholic university of Korea, St. Vincent's Hospital
    • Contact: Keon-woong Moon, MD
    • Principal Investigator: Keon-woong Moon, MD
  • Ulsan, Korea, Republic of
    • Recruiting
    • Ulsan University Hospital
    • Contact: Sang-Gon Lee, MD, PhD
    • Principal Investigator: Sang-Gon Lee, MD, PhD
  • Wonju, Korea, Republic of
    • Recruiting
    • Wonju Christian Hospital
    • Contact: Junghan Yoon
• Malaysia
  • Kuching, Malaysia
    • Recruiting
    • Sarawak General Hospital
    • Contact: K.H. Shim
    • Principal Investigator: K.H. Shim
• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Shin Kong Hospital
    • Contact: Jun-Jack Cheng
• Thailand
  • Bangkok, Thailand
    • Recruiting
    • Siriraj Hospital
    • Contact: D. Tresukosol
    • Principal Investigator: D. Tresukosol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive patients with unprotected LMCA diseases at participating centers will be evaluated for the entry into the study.

Description

Inclusion Criteria:

• Significant unprotected left main stenosis (>50% by visual estimation)

  • The LMCA is considered unprotected if there are no patent coronary artery bypass grafts to the left anterior descending artery or the left circumflex artery.
• No limitation of clinical or lesion characteristics
• Age >18 years
• The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion Criteria:

• Protected left main stenosis

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Left Main disease; Consecutive patients with unprotected LMCA diseases at participating centers will be evaluated for the entry into the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite event rate of death, myocardial infarction, Target Vessel Revascularization or cerebrovascular event	A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.	2-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death		10-year
Cardiac death		10-year
Myocardial infarction		10-year
Cerebrovascular event		10-year
Target vessel revascularization		10-year
Target lesion revascularization		10-year
Stent thrombosis	According to Academic Research Consortium (ARC) criteria	10-year
Binary restenosis and late luminal loss in both in-stent and in-segment	Angiographic follow-up in the PCI group (as form of PCI substudy)	9-month
Rehospitalization		10-year

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea
• Investigators: Principal Investigator: Seung-Jung Park, MD, PhD, CVRF

Publications and helpful links

General Publications

• Cho S, Kang DY, Kim JS, Park DW, Kim IS, Kang TS, Ahn JM, Lee PH, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Lee SJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Jang Y, Hong MK, Park SJ. Dual antiplatelet therapy after percutaneous coronary intervention for left main coronary artery disease. Rev Esp Cardiol (Engl Ed). 2022 Jul 27:S1885-5857(22)00203-1. doi: 10.1016/j.rec.2022.07.007. Online ahead of print. English, Spanish.
• Park S, Ahn JM, Park H, Kang DY, Lee PH, Kim TO, Lee J, Kim JH, Yang Y, Jeong YJ, Hyun J, Kim AR, Kim T, Oh HJ, Lee YJ, Lee JH, Jang M, Park DW, Park SJ; IRIS-MAIN Registry Investigators. Comparison of Long-Term Outcomes Following Coronary Revascularization in Men-vs-Women with Unprotected Left Main Disease. Am J Cardiol. 2021 Aug 15;153:9-19. doi: 10.1016/j.amjcard.2021.05.016. Epub 2021 Jul 4.
• Park S, Ahn JM, Kim TO, Park H, Kang DY, Lee PH, Jeong YJ, Hyun J, Lee J, Kim JH, Yang Y, Choe K, Park SJ, Park DW; IRIS-MAIN Registry Investigators. Revascularization in Patients With Left Main Coronary Artery Disease and Left Ventricular Dysfunction. J Am Coll Cardiol. 2020 Sep 22;76(12):1395-1406. doi: 10.1016/j.jacc.2020.07.047.
• Kang SH, Ahn JM, Lee CH, Lee PH, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park DW, Park SJ. Differential Event Rates and Independent Predictors of Long-Term Major Cardiovascular Events and Death in 5795 Patients With Unprotected Left Main Coronary Artery Disease Treated With Stents, Bypass Surgery, or Medication: Insights From a Large International Multicenter Registry. Circ Cardiovasc Interv. 2017 Jul;10(7):e004988. doi: 10.1161/CIRCINTERVENTIONS.116.004988.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2007
• Primary Completion (Anticipated): December 1, 2032
• Study Completion (Anticipated): December 1, 2033

Study Registration Dates

• First Submitted: April 22, 2011
• First Submitted That Met QC Criteria: April 22, 2011
• First Posted (Estimate): April 25, 2011

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: Left Main
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: CVRF2010-08

Plan for Individual participant data (IPD)

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