Exploring the MEchanism of Plaque Rupture in Acute Coronary Syndrome Using Coronary CT Angiography and computationaL Fluid Dynamics (EMERALD)
试验速览
- 阶段
- 不适用
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- The difference of area under curve between prediction model with adverse plaque characteristics and model with adverse plaque characteristics and hemodynamic forces
研究概览
简要总结
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.
详细描述
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
- To explore the interaction between hemodynamic forces measured by computational fluid dynamics (CFD) analysis and plaque vulnerability in culprit lesion of subsequent clinical events.
- 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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
The difference of area under curve between prediction model with adverse plaque characteristics and model with adverse plaque characteristics and hemodynamic forces
时间窗: 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
时间窗: 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
次要结局
- 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 association between axial plaque stress and the parameter reflecting plaque geometry (radius gradient).(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 differences in axial plaque 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 validity of rupture risk score which constructed from the predicting model.(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)
- 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)
研究者
Bon-Kwon Koo
Professor
Seoul National University Hospital