Observing treatments for severe coronary artery disease

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

This study is trying to see how well different treatments for severe coronary artery disease work for patients over time.

Quick facts

• Study type: Observational
• Enrollment: 10000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CardioVascular Research Foundation, Korea (other)
• Locations: 42 sites (Shanghai and 41 other locations)
• Trial ID: NCT01341327 on ClinicalTrials.gov

What this trial studies

This observational study aims to track the long-term clinical outcomes of patients with unprotected left main coronary artery disease. It evaluates the effectiveness of three treatment approaches: medical therapy, coronary stenting with drug-eluting stents, and coronary artery bypass grafting (CABG). The study will collect data from approximately 5000 patients across 65 centers in the Asia-Pacific region, providing insights into real-world treatment results. The findings will help inform best practices for managing this serious condition.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with significant unprotected left main coronary artery stenosis.

Not a fit: Patients with protected left main stenosis will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with severe coronary artery disease.

How similar studies have performed: Other studies have shown success in evaluating treatment outcomes for coronary artery disease, making this approach relevant and potentially impactful.

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

Where this trial is running

Shanghai and 41 other locations

• Zhongshan Hospital — Shanghai, China (RECRUITING)
• Sarawak General Hospital — Kuching, Malaysia (RECRUITING)
• Hallym University medical center — Anyang, South Korea (RECRUITING)
• Soonchunhyang University Hospital, Buchen — Bucheon-si, South Korea (TERMINATED)
• The Catholic University of Korea, Bucheon ST.Mary's Hospital — Bucheon-si, South Korea (TERMINATED)
• Inje University Busan Paik Hospital — Busan, South Korea (RECRUITING)
• Soonchunhyang University Hospital, Cheonan — Cheonan, South Korea (RECRUITING)
• St.Mary's Catholic Medical Center — Cheongju-si, South Korea (TERMINATED)
• Daegu Catholic University Medical Center — Daegu, South Korea (RECRUITING)
• Keimyung University Dongsan Medical Center — Daegu, South Korea (RECRUITING)
• Yeungnam University Medical Center — Daegu, South Korea (TERMINATED)
• Chungnam National University Hospital — Daejeon, South Korea (RECRUITING)
• The Catholic University of Korea, Daejeon ST.Mary's Hospital — Daejeon, South Korea (TERMINATED)
• Gangneung Asan Medical Center — Gangneung, South Korea (RECRUITING)
• Chonnam National University Hospital — Gwangju, South Korea (RECRUITING)
• National Health Insurance Service Ilsan Hospital — Ilsan, South Korea (TERMINATED)
• St.Mary's Catholic Medical Center — Inchon, South Korea (TERMINATED)
• Chonbuk National University Hospital — Jeonju, South Korea (RECRUITING)
• Presbyterian Medical Center — Jeonju, South Korea (RECRUITING)
• Kwangju Christian hospital — Kwangju, South Korea (RECRUITING)
• Pusan Natioanal University Hospital — Pusan, South Korea (RECRUITING)
• Bundang CHA Hospital — Seongnam, South Korea (TERMINATED)
• Asan Medical Center — Seoul, South Korea (RECRUITING)
• Dongguk University Medical Center — Seoul, South Korea (RECRUITING)
• Gangnam Severance Hospital — Seoul, South Korea (RECRUITING)
• Kangbuk samsung hospital — Seoul, South Korea (RECRUITING)
• Kangdong Sacred Heart Hospital — Seoul, South Korea (RECRUITING)
• Korea University Anam hospital — Seoul, South Korea (RECRUITING)
• Korea University Guro Hospital — Seoul, South Korea (RECRUITING)
• Seoul National University Boramae Medical Center — Seoul, South Korea (RECRUITING)
• Seoul National University Hospital — Seoul, South Korea (RECRUITING)
• Seoul Veterans Hospital — Seoul, South Korea (TERMINATED)
• St.Mary's Catholic Medical Center — Seoul, South Korea (TERMINATED)
• The Catholic University of Korea, ST. Paul's Hospital — Seoul, South Korea (TERMINATED)
• The Catholic University of Korea, Yeouido ST. Mary's Hospital — Seoul, South Korea (TERMINATED)
• Yonsei University Medical Center — Seoul, South Korea (TERMINATED)
• Ajou University Hospital — Suwon, South Korea (TERMINATED)
• The Catholic University of Korea, ST. Vincent's Hospital — Suwon, South Korea (RECRUITING)
• Ulsan University Hospital — Ulsan, South Korea (RECRUITING)
• Wonju Christian Hospital — Wŏnju, South Korea (RECRUITING)
• Shin Kong Hospital — Taipei, Taiwan (RECRUITING)
• Siriraj Hospital — Bangkok, Thailand (RECRUITING)

Study contacts

• Principal investigator: Seung-Jung Park, MD, PhD — CVRF
• Study coordinator: Seung-Jung Park, MD, PhD

Conditions: Coronary Artery Disease, Left Main