Clinical trial NCT03591328: Exploring the Mechanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and Computational Fluid Dynamics II (EMERALD II) Study
Official title: Exploring the Mechanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and Computational Fluid Dynamics II (EMERALD II) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Unstable Angina
Keywords: Acute myocardial infarction
Unstable angina
Acute coronary syndrome
Computational fluid dynamics
Coronary computed tomography angiography
Fractional flow reserve
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Inje University Ilsan Paik Hospital
name: St. Mary's hostpital
name: Odense University Hospital
name: University of Milan
name: Imperial College London
name: Aarhus University Hospital
name: Semmelweis University
name: Oxford University Hospitals NHS Trust
name: Emory University
name: Ehime University Graduate School of Medicine
name: Gifu Heart Center
name: Wakayama Medical University
name: Keimyung University Dongsan Medical Center
name: Seoul National University Bundang Hospital
name: Seoul National University Hospital Healthcare System Gangnam Center
name: Chosun University Hospital
name: Chungnam National University Hospital
name: Monzino Cardiology Center
name: OLV Hospital
name: Monash Heart
name: University of British Columbia
name: MOUNT SINAI HOSPITAL
name: Tokyo Medical University Hachioji Medical Center
name: Tokai University
name: St. Luke's International Hospital
name: Aichi Medical University
name: Toyohashi Heart Center
name: Kobe University Hospital
name: National Cerebral and Cardiovascular Center, Japan
name: Shin Koga Hospital
name: Saiseikai Kumamoto Hospital
name: Tsuchiura Kyodo Hospital
name: Tokyo Medical Dental University
name: Loyola University
name: Leiden University
name: Weil Cornell Medical College
name: West Penn Allegheny Health System
name: Ulsan Hospital
name: Ulsan University Hospital
First posted: 2018-07-19
Enrollment: 429
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: discrimination index of prediction model
timeFrame: 1 months - 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Bon-Kwon Koo, MD,PhD
role: STUDY_CHAIR
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