Clinical trial NCT01341327: Observational Study for Left Main Disease Treatment
Official title: A GLOBAL, MULTICENTER, PROSPECTIVE, REAL WORLD OBSERVATIONAL STUDY FOR LEFT MAIN DISEASE TREATMENT
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: Left Main
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2011-04-25
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with unprotected LMCA diseases at participating centers will be evaluated for the entry into the study.

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Composite event rate of death, myocardial infarction, Target Vessel Revascularization or cerebrovascular event
timeFrame: 2-year
Secondary outcomes:
measure: Death
timeFrame: 10-year
measure: Cardiac death
timeFrame: 10-year
measure: Myocardial infarction
timeFrame: 10-year
measure: Cerebrovascular event
timeFrame: 10-year
measure: Target vessel revascularization
timeFrame: 10-year
measure: Target lesion revascularization
timeFrame: 10-year
measure: Stent thrombosis
timeFrame: 10-year
measure: Binary restenosis and late luminal loss in both in-stent and in-segment
timeFrame: 9-month
measure: Rehospitalization
timeFrame: 10-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
city: Anyang
country: Korea, Republic of
facility: Hallym University medical center
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Hospital, Buchen
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon ST.Mary's Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang University Hospital, Cheonan
city: Cheongju
country: Korea, Republic of
facility: St.Mary's Catholic Medical Center
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon ST.Mary's Hospital
city: Gangneung
country: Korea, Republic of
facility: Gangneung Asan Medical Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Ilsan
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
city: Inchon
country: Korea, Republic of
facility: St.Mary's Catholic Medical Center
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Jeonju
country: Korea, Republic of
facility: Presbyterian Medical Center
city: Kwangju
country: Korea, Republic of
facility: Kwangju Christian hospital
city: Pusan
country: Korea, Republic of
facility: Pusan Natioanal University Hospital
city: Seongnam
country: Korea, Republic of
facility: Bundang CHA Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Dongguk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk samsung hospital
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Veterans Hospital
city: Seoul
country: Korea, Republic of
facility: St.Mary's Catholic Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, ST. Paul's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, ST. Vincent's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
city: Taipei
country: Taiwan
facility: Shin Kong Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: CVRF
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.