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临床试验/NCT05029661
NCT05029661Unknown不适用

Ultrafast Ultrasonic COMpound Push Wave imAging and Strain eStimation (Ultra-COMPASS) for Individual Plaque Stratification in the Carotid Arteries

Radboud University Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年11月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Alterations in plaque composition

研究概览

简要总结

Ischemic strokes are a leading cause of death and disability worldwide. In 20% of cases they are caused by the rupture of atherosclerotic plaques in carotid arteries. Risk estimation of plaque rupture is currently suboptimal. Although pathology studies have shown that plaque composition provides a better risk assessment (lipid-rich core with thin fibrous cap = high risk (unstable plaque); fibrous core and a thick fibrous cap = low risk (stable plaque)), plaque composition cannot be determined using imaging techniques, and can therefore not be assessed non-invasively. Ultrasound, which is already widely used in clinical practice to determine plaque geometry could be an optimal technique to determine plaque composition and monitor plaques in a large population, due to its low patient burden, relatively low cost and speed of measurement. However, using conventional ultrasound it is not possible to reliably determine plaque composition. However, this might be possible using newly developed ultrasound functionalities(shear wave and strain elastography) enabling tissue stiffness estimation. It is known that recurrence risk is greatest in the first week after a stroke or transient ischemic attack (TIA) and decreases afterwards, probably due to a stabilization of the plaque due to a change in composition. Additionally, lipid-lowering medication is known to further reduce the recurrence risk after such an event, probably due to an acceleration of the stabilization process of the plaque. In this study, the investigators want to investigate whether Ultra-COMPASS ultrasound measurements (a combination of shear wave and strain elastography and ultrafast compounding (a fast variant of standard anatomical ultrasound to determine plaque geometry)) could be used to determine changes in plaque composition after a stroke / TIA.

Primary objective:

Investigate whether it is possible to detect plaque stabilization, determined by plaque stiffness, after a brain infarction or transient ischemic attack with Ultra-COMPASS ultrasound measurements.

Secundary objectives:

  • Determine the association between (changes in) Ultra-COMPASS measurements and the lipid-lowering drugs used 6 and 12 weeks after ischemic stroke.
  • Determine the association between Ultra-COMPASS measurements and recurrent cardiovascular events (TIA / cerebral infarction / myocardial infarction/death) 6 and 12 weeks after ischemic stroke.
  • Determine the association between Ultra-COMPASS measurements and (changes in) low-density lipoprotein levels 6 and 12 weeks after ischemic stroke (if known).

Study design:

This is a prospective, longitudinal, observational, single-center cohort study in patients after a cerebral infarction or TIA with stenosis of one / both carotid arteries of 30-70% that receive or start withcholesterol-lowering medication. Ultra-COMPASS measurements will be taken within 7 days after brain infarction/TIA and at 6 ± 1 and after 12 ± 1 weeks in both carotid arteries to see if plaques stabilize overtime and to what extent medication stimulates a beneficial change in plaque composition.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Transient ischemic attack in anterior flow area (with diffusion restriction on DWI/ADC sequences of the cerebral MRI, corresponding to recent ischemia) or clinical diagnosis of brain infarction (cerebral CT for exclusion of brain haemorrhage)
  • Opportunity to undergo Ultra-COMPASS ultrasound measurements ≤7 days after initiation of first clinical symptoms
  • Stenosis 30-70% of carotid arteries based on clinically performed carotid ultrasound or thickening of at least 2mm on CT/MR scan
  • Signed informed consent

排除标准

  • Total occlusion common carotid artery or internal carotid artery
  • Cardio-embolic nature of ischemic stroke (a.o. atrial fibrilation, valvular prothesis, endocarditis, recent myocardialinfarction)
  • Restenosis after carotid endarterectomy
  • Acute myocardial infarction
  • Radiotherapy-induced carotid stenosis

结局指标

主要结局

Alterations in plaque composition

时间窗: 6 and 12 weeks

Change in plaque composition (= change in plaque stiffness) measured with Ultra-COMPASS measurements (i.e. shear wave and strain elastography and plaque geometry) in patients with and without a change in lipid-lowering medication regimen

次要结局

  • Lipoprotein level effect(6 and 12 weeks after ischemic stroke (if known).)
  • Recurrent cardiovascular events(up to 12 weeks after brain infarction/TIA)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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