Acute Coronary Syndrome, Myocardial Infarction, Plaque, Atherosclerotic, Rupture, Spontaneous
Conditions
Keywords
axial plaque stress, pressure, pressure gradient, coronary plaque, plaque rupture, acute coronary syndrome, acute myocardial infarction, computational fluid dynamics, coronary computed tomography angiography, wall shear stress
Brief summary
The EMERALD trial is a multinational, multicenter study. The patients presented with AMI/definite evidence of plaque rupture and had underwent coronary CT angiography from 1 month to 2 year prior to the event will be retrospectively searched. Plaques in the non-culprit vessels will be regarded as internal control to the ruptured plaque in the culprit vessel.
Detailed description
The mechanisms of plaque rupture have not been fully understood. Hemodynamic forces acting on the plaque, plaque vulnerability, and the interaction between two factors might be the most important mechanism to explain various feature and location of plaque rupture. The objectives of the study are 1. To explore the interaction between hemodynamic forces measured by computational fluid dynamics (CFD) analysis and plaque vulnerability in culprit lesion of subsequent clinical events. 2. To build rupture risk scoring system, incorporating independent predictor for plaque rupture. The EMERALD trial is a multinational and multicenter study. The patients presented with AMI/plaque rupture and had underwent coronary CT angiography from 1 month to 2 year prior to the event will be retrospectively searched. Plaques in the non-culprit vessels will be regarded as internal control to the ruptured plaque in the culprit vessel. The enrollment criteria will be 1. Patients who presented with acute coronary syndrome with cardiac enzyme elevation (AMI)/plaque rupture. 2. Among those patients, the patients who underwent coronary CT angiography, regardless of the reason prior to the acute event will be searched. The time limit of coronary CT angiography will be 1 month \ 2 year prior to the event. The Computational Fluids Dynamics (CFD) and Fluid-Structural Interaction (FSI) simulation will be performed to comprehensively evaluate the total plaque forces and their interaction with the plaque. The comparison groups will be defined as follows; The plaque in the culprit vessel of AMI will be defined the Group A. The plaque in the non-culprit vessel of AMI will be defined as internal control, Group B.
Interventions
None listed
Sponsors
HeartFlow, Inc.
Kyoto University, Graduate School of Medicine
Inje University
Keimyung University Dongsan Medical Center
Ulsan University Hospital
Wakayama Medical University
Aarhus University Hospital
Seoul National University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who experienced acute myocardial infarction from 2010-2014 whose diagnosis have confirmed by invasive coronary angiography with or without IVUS or OCT evaluation, and who underwent coronary CT angiography from 1 month to 2 year prior to the acute myocardial infarction event.
Exclusion criteria
* Acute coronary syndrome without cardiac enzyme elevation (unstable angina) * Patients who did not underwent coronary CT angiography, 1 month to 2 years prior to the acute myocardial infarction * Poor CT images (unable to reconstruct 3 dimensional coronary artery model) * The time period between coronary CT angiography and acute myocardial infarction exceed more than 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference of area under curve between prediction model with adverse plaque characteristics and model with adverse plaque characteristics and hemodynamic forces | from 1 month - 2 year | Model 1 : percent diameter stenosis + adverse plaque characteristics defined by CT angiography Model 2 : percent diameter stenosis + adverse plaque characteristics defined by CT angiography + Hemodynamic forces defined by computational fluid dynamics |
| The difference of net reclassification index between prediction model with adverse plaque characteristics and model with adverse plaque characteristics and hemodynamic forces | from 1 month - 2 year | Model 1 : percent diameter stenosis + adverse plaque characteristics defined by CT angiography Model 2 : percent diameter stenosis + adverse plaque characteristics defined by CT angiography + Hemodynamic forces defined by computational fluid dynamics |
Secondary
| Measure | Time frame |
|---|---|
| The independent predictors for the plaque rupture using generalized estimating equation, and the c-index of the predicting models. | from 1 month - 2 year |
| The validity of rupture risk score which constructed from the predicting model. | from 1 month - 2 year |
| The differences in other hemodynamic parameters for example, pressure gradient, delta pressure, FFRCT, average and peak wall shear stress between Group A and Group B. | from 1 month - 2 year |
| The best cut-off value of axial plaque stress to induce plaque rupture. | from 1 month - 2 year |
| The differences in axial plaque stress between Group A and Group B | from 1 month - 2 year |
| The differences in plaque vulnerability (Housefiled unit of the plaque on CT) between Group A and Group B | from 1 month - 2 year |
| The association between axial plaque stress and the parameter reflecting plaque geometry (radius gradient). | from 1 month - 2 year |
| The threshold of the plaque vulnerability (Housefiled unit of the plaque on CT) to induce rupture. | from 1 month - 2 year |
Countries
South Korea
Outcome results
None listed