Observational Study for Left Main Disease Treatment

NCT ID: NCT01341327

Last Updated: 2024-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2033-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Left Main disease

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Seung-Jung Park

OTHER

Sponsor Role lead

Responsible Party

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Seung-Jung Park

MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Seung-Jung Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CVRF

Locations

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Zhongshan Hospital

Shanghai, , China

Site Status RECRUITING

Sarawak General Hospital

Kuching, , Malaysia

Site Status RECRUITING

Hallym University medical center

Anyang, , South Korea

Site Status RECRUITING

Soonchunhyang University Hospital, Buchen

Bucheon-si, , South Korea

Site Status TERMINATED

The Catholic University of Korea, Bucheon ST.Mary's Hospital

Bucheon-si, , South Korea

Site Status TERMINATED

Inje University Busan Paik Hospital

Busan, , South Korea

Site Status RECRUITING

Soonchunhyang University Hospital, Cheonan

Cheonan, , South Korea

Site Status RECRUITING

St.Mary's Catholic Medical Center

Cheongju-si, , South Korea

Site Status TERMINATED

Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status RECRUITING

Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status RECRUITING

Yeungnam University Medical Center

Daegu, , South Korea

Site Status TERMINATED

Chungnam National University Hospital

Daejeon, , South Korea

Site Status RECRUITING

The Catholic University of Korea, Daejeon ST.Mary's Hospital

Daejeon, , South Korea

Site Status TERMINATED

Gangneung Asan Medical Center

Gangneung, , South Korea

Site Status RECRUITING

Chonnam National University Hospital

Gwangju, , South Korea

Site Status RECRUITING

National Health Insurance Service Ilsan Hospital

Ilsan, , South Korea

Site Status TERMINATED

St.Mary's Catholic Medical Center

Inchon, , South Korea

Site Status TERMINATED

Chonbuk National University Hospital

Jeonju, , South Korea

Site Status RECRUITING

Presbyterian Medical Center

Jeonju, , South Korea

Site Status RECRUITING

Kwangju Christian hospital

Kwangju, , South Korea

Site Status RECRUITING

Pusan Natioanal University Hospital

Pusan, , South Korea

Site Status RECRUITING

Bundang CHA Hospital

Seongnam, , South Korea

Site Status TERMINATED

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Dongguk University Medical Center

Seoul, , South Korea

Site Status RECRUITING

Gangnam Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Kangbuk samsung hospital

Seoul, , South Korea

Site Status RECRUITING

Kangdong Sacred Heart Hospital

Seoul, , South Korea

Site Status RECRUITING

Korea University Anam hospital

Seoul, , South Korea

Site Status RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Seoul Veterans Hospital

Seoul, , South Korea

Site Status TERMINATED

St.Mary's Catholic Medical Center

Seoul, , South Korea

Site Status TERMINATED

The Catholic University of Korea, ST. Paul's Hospital

Seoul, , South Korea

Site Status TERMINATED

The Catholic University of Korea, Yeouido ST. Mary's Hospital

Seoul, , South Korea

Site Status TERMINATED

Yonsei University Medical Center

Seoul, , South Korea

Site Status TERMINATED

Ajou University Hospital

Suwon, , South Korea

Site Status TERMINATED

The Catholic University of Korea, ST. Vincent's Hospital

Suwon, , South Korea

Site Status RECRUITING

Ulsan University Hospital

Ulsan, , South Korea

Site Status RECRUITING

Wonju Christian Hospital

Wŏnju, , South Korea

Site Status RECRUITING

Shin Kong Hospital

Taipei, , Taiwan

Site Status RECRUITING

Siriraj Hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

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China Malaysia South Korea Taiwan Thailand

Central Contacts

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Seung-Jung Park, MD, PhD

Role: CONTACT

82-2-3010-3152

Facility Contacts

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Junbo Ge

Role: primary

K.H. Shim

Role: primary

Woo-jung Park, MD

Role: primary

Tae-hyun Yang, MD

Role: primary

Won Yong Shin

Role: primary

Kee-sik Kim, MD

Role: primary

Seung-ho Hur, MD

Role: primary

Jin-ok Jeong, MD

Role: primary

Sang-sig Cheong, MD

Role: primary

Myung-ho Jeong, MD

Role: primary

Jei-keon Chae, MD

Role: primary

Jay-young Rhew, MD

Role: primary

Seung-uk Lee, MD

Role: primary

June-Hong Kim, MD, PhD

Role: primary

Seung-jung Park, MD

Role: primary

Deuk-young Nah, MD

Role: primary

Hyuck-moon Kwon, MD

Role: primary

Byung-jin Kim, MD

Role: primary

Kyoo-rok Han, MD

Role: primary

Do-sun Lim, MD

Role: primary

Seung-un Na, MD

Role: primary

Woo-young Chung, MD

Role: primary

Hyo-Soo Kim, MD, PhD

Role: primary

Keon-woong Moon, MD

Role: primary

Sang-Gon Lee, MD, PhD

Role: primary

Junghan Yoon

Role: primary

Jun-Jack Cheng

Role: primary

D. Tresukosol

Role: primary

References

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Kim TO, Kang DY, Ahn JM, Kim MJ, Lee PH, Kim H, Choi Y, Lee J, Lee JM, Jo HH, Park YS, Lim SM, Park SJ, Park DW. Impact of Target Lesion Revascularization on Long-Term Mortality After Percutaneous Coronary Intervention for Left Main Disease. JACC Cardiovasc Interv. 2024 Jan 8;17(1):32-42. doi: 10.1016/j.jcin.2023.10.068.

Reference Type DERIVED
PMID: 38199751 (View on PubMed)

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). 2023 Apr;76(4):245-252. doi: 10.1016/j.rec.2022.07.007. Epub 2022 Jul 27. English, Spanish.

Reference Type DERIVED
PMID: 35907438 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34233836 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32943156 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28701487 (View on PubMed)

Other Identifiers

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CVRF2010-08

Identifier Type: -

Identifier Source: org_study_id

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