Hemodynamic Change of Coronary Atherosclerotic Plaque After Evolocumab Treatment: A Serial Follow-Up Study by Computed Tomography-Derived Fractional Flow Reserve
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- the change of lesion-specific CT-FFR
研究概览
简要总结
Compelling evidences indicate that lipid-lowering therapy can reduce the high-risk plaque feathers and improve the coronary flow reserve. This study is going to investigate the change of lesion-specific hemodynamic significance as determined by ML(Machine Learning)-based CT-FFR (Computed Tomography-Fractional Flow Reserve)after Evolocumab treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.baseline CCTA revealed at least one lesion with stenotic extent from 50% to 69% on major epicardial arteries (diameter ≧2 mm);
- •2.patients were referred for optimal medical treatment;
- •3.patients agreed to undergo follow-up CCTA at 1-year interval.
排除标准
- •1.patients had previous history of myocardial infarction or coronary revascularization;
- •2.patients were contraindicated to the usage of iodine contrast media;
- •3.image quality of baseline or follow-up CCTA was severely impaired (in presence of severe artifact, non-diagnostic);
- •4.patients withdrew the informed consents during follow-up;
- •5.patients experienced major adverse cardiac events during follow-up;
- •6.patients refused to undergo follow-up CCTA;
- •7.lost follow-up
结局指标
主要结局
the change of lesion-specific CT-FFR
时间窗: June 2020 to December 2021
After one year's treatment of Elovocumab Injection, the patients will undergo follow-up CCTA again. We will measure the proximal and distal CT-FFR for each lesion.At the same time ,we will calculated the change in CT-FFR value across the lesion(ΔCT-FFR=CT-FFRproximal-CT-FFRdistal).To compare the parameters above,we shall identify whether the treatment of Elovocumab Injection improves the lesion-specific CT-FFR.
次要结局
未报告次要终点