Prediction of Vulnerable Plaque Using Coronary CT Angiography and Computational Fluid Dynamic in Acute Coronary Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- The difference of net reclassification index (NRI) and integrated discrimination improvement (IDI) among the three prediction models
研究概览
简要总结
The aim of the PVCFD trial is to predict vulnerable plaque confirmed by OCT using coronary CT angiography and computational fluid dynamics in patients with acute coronary syndrome.
详细描述
Acute coronary syndrome（ACS）mainly includes unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction, which is the leading cause of death around the world. The main pathophysiological feature of ACS is the rupture of vulnerable plaque, which can be recognized by coronary artery angiography (CAG), intravascular ultrasound (IVUS) and optical coherence tomography (OCT). Compared with CAG and IVUS, OCT is the best intravascular imaging technique so far. But all these examinations are invasive and expensive. Recently, coronary CT angiography derived adverse plaque characteristics (APC) and hemodynamic forces defined by computational fluid dynamics (CFD) can reflect plaque vulnerability and hemodynamic forces acting on the plaque, which are important factors in the progress of the rupture of vulnerable plaque. So, we want to explore predictive value of coronary CT angiography (CTA)and computational fluid dynamics for vulnerable plaque in ACS.
The PVCFD trial is a prospective and single center study, patients with ACS will be arranged to complete coronary CTA before CAG. OCT will be used to detect the characteristics of coronary atherosclerotic plaques confirmed by CAG. Lipid plaques with fibrous cap thickness less than 65um, erosion and coronary artery dissection are defined as vulnerable plaque. Patients will be divided into vulnerable plaque group and stable plaque group according to this. The coronary CTA images will be screened for APC and CFD analyses at core laboratories of Shanghai tenth's hospital. Lesions with diameter stenosis (DS) >30% based on coronary CTA evaluation were included for subsequent APC (low-attenuation plaque, positive remodeling, napkin-ring sign, and spotty calcification) analysis and hemodynamic forces (FFRCT,ΔFFRCT, WSS and PWS) defined by CFD. Three prediction models (Model 1: percent diameter stenosis + lesion length, Model 2: Model 1 + APC, Model 3: Model 2 + hemodynamic force) will be constructed to identify vulnerable plaque confirmed by OCT.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute coronary syndrome was diagnosed according to universal definition of ACS; and 2) coronary CTA was completed before CAG; and 3) definitely culprit lesion can be recognized by CAG; 4) OCT was done to detect coronary atherosclerotic plaques confirmed by CAG.
排除标准
- •Previous history stent implantation; 2) previous history of coronary artery bypass graft surgery; 3) ACS without clear culprit lesion; 4) poor image quality of coronary CTA for APC and CFD analysis; 5) myocardial infarction secondary to other reasons
结局指标
主要结局
The difference of net reclassification index (NRI) and integrated discrimination improvement (IDI) among the three prediction models
时间窗: from 1 to 72 hours
The difference of area under curve among the three prediction models
时间窗: from 1 to 72 hours
次要结局
- The optimal cut-off values of hemodynamic parameters (FFRCT,ΔFFRCT, WSS and PWS) to identify vulnerable plaque(from 1 to 72 hours)
- The percentage in APC (low-attenuation plaque, positive remodeling, napkin-ring sign, and spotty calcification) between the vulnerable plaque group and stable plaque group(from 1 to 72 hours)
- The difference in hemodynamic parameters (FFRCT,ΔFFRCT, WSS and PWS) between the vulnerable plaque group and stable plaque group(from 1 to 72 hours)
研究者
Ya-Wei Xu
MD, pHD, Director of Cardiovascular Department
Shanghai 10th People's Hospital