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

August 19, 2022 updated by: Bon-Kwon Koo, Seoul National University Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The mechanisms of plaque rupture are not fully understood. Hemodynamic forces, plaque vulnerability, and the interaction between these factors may cause plaque instability and subsequent acute coronary syndrome (ACS). Previously, the first-in-human study, EMERALD I, showed that the addition of hemodynamic parameters calculated noninvasively from coronary computed tomography (CCTA) using computational fluid dynamics (CFD) improved the ability to predict the risk of ACS compared with conventional approaches based on anatomical stenosis severity and adverse plaque characteristics. In addition to hemodynamic properties, quantified compositional plaque volumes such as fibrofatty and necrotic core volume (FFNC) or low-attenuation plaque burden (% plaque to vessel volume) have been proven to be robust prognostic indicators of ACS. While various hemodynamic and plaque features predictive of ACS have been introduced, the relative importance among them and the additive value of the risk model with the best features over the current diagnostic scheme of CCTA have not been proposed. In this regard, we designed the subsequent EMERALD II study to find the best hemodynamic and plaque features in prediction of ACS from comprehensive CCTA analysis, including per-lesion and per-vessel plaque quantification and hemodynamic analysis, and to investigate whether a comprehensive risk prediction model with them has an incremental value in a larger population.

Study Type

Observational

Enrollment (Anticipated)

429

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who presented with acute coronary syndrome (acute myocardial infarction or unstable angina) and had undergone CCTA from 1 months to 3 years prior to the event.

Description

Inclusion Criteria:

  1. Patients who presented with ACS* and underwent invasive coronary angiography with identifiable culprit lesion
  2. The patients who underwent coronary CT angiography, regardless of the reason (for example, routine healthcare check-up, or evaluation for stable angina or atypical chest pain) prior to the acute event.

  3. Time limit of CCTA: 1 months ~ 3 years prior to the event.

    • Definition of ACS:

A. The patients with acute myocardial infarction should have cardiac enzyme elevation and identified culprit lesion confirmed by invasive coronary angiography, IVUS, or OCT.

B. The patients with unstable angina should have evidence of plaque rupture, which includes at least one of the following: (1) the presence of plaque rupture or haziness including thrombus at invasive coronary angiography, (2) angiographic stenosis ≥90%, or (3) the evidence of rupture confirmed by IVUS or OCT.

Exclusion criteria for Patient enrollment

  1. Patients with ACS without clear evidence of culprit lesion
  2. Patients with stents in two or more vessel territories prior to CCTA
  3. Poor quality of CCTA which is unsuitable for plaque and CFD analysis
  4. Patients with ACS culprit lesion in a stented segment
  5. Patients with previous history of coronary artery bypass graft surgery
  6. Patients with revascularization after CCTA and before ACS event (*Patients with elective PCI for 1 vessel within 3 month after CCTA can be enrolled.
  7. Secondary ACS due to other general medical conditions, such as sepsis, arrhythmia, bleeding, etc.
  8. Patients with unstable angina without evidence of plaque rupture Additional exclusion criteria for Computational Fluid Dynamics
  9. Poor quality CCTA images unsuitable for CFD and plaque analysis
  10. No unprocessed CCTA data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Culprit
Plaques which is related with acute coronary syndrome
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.
Non-culprit
Plaques which is not related with acute coronary syndrome
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
discrimination index of prediction model
Time Frame: 1 months - 3 years
discrimination index of prediction model
1 months - 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Odense University Hospital
University of British Columbia
Aarhus University Hospital
Emory University
Imperial College London
Ulsan University Hospital
Seoul National University Bundang Hospital
West Penn Allegheny Health System
Leiden University
MOUNT SINAI HOSPITAL
National Cerebral and Cardiovascular Center
Keimyung University Dongsan Medical Center
Semmelweis University
University of Milan
Chungnam National University Hospital
Loyola University
Wakayama Medical University
Chosun University Hospital
Gifu Heart Center
Ehime University Graduate School of Medicine
Tokai University
Inje University Ilsan Paik Hospital
Oxford University Hospital
St. Mary's hostpital
Seoul National University Hospital Healthcare System Gangnam Center
Monzino Cardiology Center
OLV Hospital
Monash Heart
Tokyo Medical University Hachioji Medical Center
St. Luke's International Hospital
Aichi Medical University
Toyohashi Heart Center
Kobe University Hospital
Shin Koga Hospital
Saiseikai Kumamoto Hospital
Tsuchiura Kyodo Hospital
Tokyo Medical Dental University
Weil Cornell Medical College
Ulsan Hospital

Investigators

  • Study Chair: Bon-Kwon Koo, MD,PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2018

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

July 8, 2018

First Submitted That Met QC Criteria

July 8, 2018

First Posted (Actual)

July 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT1869

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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