Exploring the Mechanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and Computational Fluid Dynamics II (EMERALD II) Study

NCT03591328 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 429

Last updated 2022-08-23

No results posted yet for this study

Summary

The EMERALD II study is a multinational, multicenter, and retrospective study. ACS patients who underwent CCTA from 1 months to 3 years prior to the event will be retrospectively identified. Plaques in the non-culprit vessels will be regarded as a primary control group.

Conditions

  • Acute Myocardial Infarction
  • Unstable Angina

Interventions

DIAGNOSTIC_TEST

Coronary CT angiography

Comprehensive CCTA analysis of all culprit and non-culprit lesions to obtain their per-lesion and per-vessel quantitative, qualitative plaque, and hemodynamic features is performed by the independent core laboratory (HeartFlow, Mountain View, CA, USA) blinded to patient characteristics and ICA findings. The current CCTA reporting variables, including % diameter stenosis, segment involvement score (SIS), and HRP features, are obtained for all lesions by another independent core laboratory (University of British Columbia, Vancouver, Canada) to construct a reference model. ICA and invasive imaging studies performed at the event of ACS are analyzed by the independent core laboratory (Samsung Medical Center, Seoul, Korea) to define the culprit lesion blinded to CCTA findings. Other independent experts match culprit and non-culprit lesion data between ICA and CCTA findings.

Sponsors & Collaborators

  • Inje University Ilsan Paik Hospital

    collaborator OTHER
  • St. Mary's hostpital

    collaborator UNKNOWN
  • Odense University Hospital

    collaborator OTHER
  • University of Milan

    collaborator OTHER
  • Imperial College London

    collaborator OTHER
  • Aarhus University Hospital

    collaborator OTHER
  • Semmelweis University

    collaborator OTHER
  • Oxford University Hospitals NHS Trust

    collaborator OTHER
  • Emory University

    collaborator OTHER
  • Ehime University Graduate School of Medicine

    collaborator OTHER
  • Gifu Heart Center

    collaborator OTHER
  • Wakayama Medical University

    collaborator OTHER
  • Keimyung University Dongsan Medical Center

    collaborator OTHER
  • Seoul National University Bundang Hospital

    collaborator OTHER
  • Seoul National University Hospital Healthcare System Gangnam Center

    collaborator UNKNOWN
  • Chosun University Hospital

    collaborator OTHER
  • Chungnam National University Hospital

    collaborator OTHER
  • Monzino Cardiology Center

    collaborator UNKNOWN
  • OLV Hospital

    collaborator UNKNOWN
  • Monash Heart

    collaborator UNKNOWN
  • University of British Columbia

    collaborator OTHER
  • MOUNT SINAI HOSPITAL

    collaborator OTHER
  • Tokyo Medical University Hachioji Medical Center

    collaborator UNKNOWN
  • Tokai University

    collaborator OTHER
  • St. Luke's International Hospital

    collaborator UNKNOWN
  • Aichi Medical University

    collaborator OTHER
  • Toyohashi Heart Center

    collaborator OTHER
  • Kobe University Hospital

    collaborator UNKNOWN
  • National Cerebral and Cardiovascular Center, Japan

    collaborator OTHER
  • Shin Koga Hospital

    collaborator UNKNOWN
  • Saiseikai Kumamoto Hospital

    collaborator UNKNOWN
  • Tsuchiura Kyodo Hospital

    collaborator UNKNOWN
  • Tokyo Medical Dental University

    collaborator UNKNOWN
  • Loyola University

    collaborator OTHER
  • Leiden University

    collaborator OTHER
  • Weil Cornell Medical College

    collaborator UNKNOWN
  • West Penn Allegheny Health System

    collaborator OTHER
  • Ulsan Hospital

    collaborator UNKNOWN
  • Ulsan University Hospital

    collaborator OTHER
  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Bon-Kwon Koo, MD,PhD · Seoul National University Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2022-09-30
Completion
2022-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03591328 on ClinicalTrials.gov