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| Name | Class |
|---|---|
| HeartFlow, Inc. | INDUSTRY |
| Kyoto University, Graduate School of Medicine | OTHER |
| Inje University | OTHER |
| Keimyung University Dongsan Medical Center |
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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.
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
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Culprit lesion) | The plaque in the culprit vessel of acute myocardial infarction will be defined the Group A. | ||
| Group B (Non-culprit lesion) | The plaque in the non-culprit vessel of acute myocardial infarction will be defined as internal control, Group B. |
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| Measure | Description | Time Frame |
|---|---|---|
| The difference of area under curve between prediction model with adverse plaque characteristics and model with adverse plaque characteristics and hemodynamic forces | 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 | from 1 month - 2 year |
| The difference of net reclassification index between prediction model with adverse plaque characteristics and model with adverse plaque characteristics and hemodynamic forces | 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 | from 1 month - 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| The best cut-off value of axial plaque stress to induce plaque rupture. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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. Acute coronary syndrome without cardiac enzyme elevation (unstable angina) will be excluded. The time limit of the coronary CT angiography prior to the event is from 1 month to 2 year. Participating center will perform abovementioned search process.
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| Name | Affiliation | Role |
|---|---|---|
| Bon-Kwon Koo, MD, PhD | Seoul National University Hospital | Study Chair |
| Bon-Kwon Koo, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Joo Myung Lee, MD, MPH | Samsung Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul national university hospital | Seoul | 110-744 | South Korea | |||
| Samsung Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29550316 | Derived | Lee JM, Choi G, Koo BK, Hwang D, Park J, Zhang J, Kim KJ, Tong Y, Kim HJ, Grady L, Doh JH, Nam CW, Shin ES, Cho YS, Choi SY, Chun EJ, Choi JH, Norgaard BL, Christiansen EH, Niemen K, Otake H, Penicka M, de Bruyne B, Kubo T, Akasaka T, Narula J, Douglas PS, Taylor CA, Kim HS. Identification of High-Risk Plaques Destined to Cause Acute Coronary Syndrome Using Coronary Computed Tomographic Angiography and Computational Fluid Dynamics. JACC Cardiovasc Imaging. 2019 Jun;12(6):1032-1043. doi: 10.1016/j.jcmg.2018.01.023. Epub 2018 Mar 14. |
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After acceptance of first manuscript, the data will be shared upon request and permission of principal investigator and participants of the study
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| OTHER |
| Ulsan University Hospital | OTHER |
| Wakayama Medical University | OTHER |
| Aarhus University Hospital | OTHER |
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| 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 association between axial plaque stress and the parameter reflecting plaque geometry (radius gradient). | 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 |
| Seoul |
| 135-710 |
| South Korea |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D009203 | Myocardial Infarction |
| D058226 | Plaque, Atherosclerotic |
| D012422 | Rupture, Spontaneous |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D020763 | Pathological Conditions, Anatomical |
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