The Changes in Carotid Plaque Neovascularization After Long-term Elovocumab Injection Therapy: A Follow-Up Study by Contrast Enhanced Ultrasonography
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The Changes in Carotid Plaque Neovascularization
研究概览
简要总结
150 selected patients will be recruited, who have at least one atherosclerotic plaque in the carotid artery that is thicker than 2.0 mm and which is determined to be uniformly or predominantly echolucent by standard ultrasonography. For each of the plaques, standard ultrasonography will be used to evaluate lesion echogenicity, while contrast-enhanced ultrasonography (CEUS) will be used to perform the visual and quantitative analysis of neovascularization. Each technique will be applied at baseline (at the time of study enrollment) and following 0.5、1 year of Elococumab Injection treatment. During the study, these patients will be treated with Elococumab Injection (1ml:140mg),ih, every two weeks.
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
- •have at least one atherosclerotic plaque in the carotid artery that is thicker than 2.0 mm and which is determined to be uniformly or predominantly echolucent by standard ultrasonography;
- •2.patients were referred for optimal medical treatment;
- •3.patients agreed to undergo follow-up CEUS at half-year and 1-year interval.
排除标准
- •1.patients had previous history of cerebral thrombosis or cerebral embolism;
- •2.patients were contraindicated to the usage of contrast media;
- •3.image quality of baseline or follow-up CEUS was severely impaired (in presence of severe artifact, non-diagnostic);
- •4.patients withdrew the informed consents during follow-up;
- •5.patients experienced major adverse cerebrovascular events during follow-up;
- •6.patients refused to undergo follow-up CEUS;
- •7.lost follow-up
结局指标
主要结局
The Changes in Carotid Plaque Neovascularization
时间窗: June 2020 to December 2021
We will use the time-signal intensity curve to calculate the changes in carotid plaque neovascularization.The time-intensity curve parameters includes: Baseline intensity(BI) and peak intensity (PI).Due to the ultrasound contrast agent, the intra-plaque signal intensity increased. Thus, enhanced intensity (EI) was calculated as follows: EI = PI - BI. EI is a parameter that measures the intensity differences between pre- and post-injections of the intravascular tracer. Relative plaque enhancement (EI-R), measured at the separate peak enhancement point in the blood and plaque, will be calculated as the ratio of enhanced intensity in the carotid artery lumen (EI-L) to the enhanced intensity in the plaque (EI-P) using the following formula: EI-R=EI-L/EI-P.
次要结局
未报告次要终点