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

Seoul National University

Status

Active, not recruiting

Conditions

Unstable Angina

Acute Myocardial Infarction

Treatments

Diagnostic Test: Coronary CT angiography

Study type

Observational

Funder types

Other

Identifiers

NCT03591328

NCT1869

Details and patient eligibility

About

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.

Full 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.

Enrollment

429 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Patients who presented with ACS* and underwent invasive coronary angiography with identifiable culprit lesion
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.
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

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