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临床试验/NCT02759653
NCT02759653已完成不适用

Norwegian Carotid Plaque Study (NOR-PLAQ). Advanced Neurosonology in Acute Ischemic Stroke

Haukeland University Hospital1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
1
主要终点
Ischemic stroke or TIA documented by Medical record

研究概览

简要总结

BACKGROUND: In 30-40% the cause of ischemic stroke remains undetermined. Most likely, this category hides an additional number of strokes caused by artery-to-artery embolisms due to unidentified atherosclerotic disease, or caused by cardioembolism. Both types are associated with a high risk of recurrent ischemic events and multiple cerebral infarctions.

Large-artery atherosclerosis of the brain-supplying arteries is the assumed underlying cause in 10 to 15% of ischemic stroke, mostly deriving from the extracranial carotid artery. Carotid intima-media thickness (cIMT) measured by 2-dimensional (2D) B-mode ultrasonography and estimation of the overall atherosclerotic plaque burden aids future risk prediction. Arterial wall changes, artery caliber variations, degree of stenosis, local hemodynamic alterations and certain plaque characteristics are important for the evaluation of plaque vulnerability and vascular risk stratification. Transcranial Doppler monitoring (TCDM) is a non-invasive bedside examination eligible for detection of microemboli in the human cerebral circulation.

HYPOTHESIS: Atherosclerotic stenosis and plaque characteristics can be more accurately assessed by the combination of routine 2D ultrasound, contrast enhanced ultrasound (CEUS), and 3-dimensional (3D) ultrasound. TCDM, CEUS and 3D visualization of the carotid plaque improve the differentiation of stroke etiology and quantification of plaque vulnerability, and aid the prediction of future risk for cerebrovascular events in the individual patient.

AIMS: Assessment of prevalence and frequency of Microemboli signals (MES) in unselected patients with cerebral ischemia, the influence of antithrombotic drugs on MES, and the relationship between MES and recurrent stroke or Transient ischemic attack (TIA).

Categorization of atherosclerotic carotid artery disease by use of routine and advanced neurosonographic techniques combined with anamnestic and clinical data.

Development of a visualization solution tailored for 3D visualization of carotid arteries and semi-automatic plaque segmentation.

详细描述

  • Standardized questionnaire
  • Extracranial and transcranial duplexsonography
  • Extracranial contrast-enhanced ultrasound
  • Extracranial 3D-ultrasound
  • Transcranial Doppler monitoring
  • Clinical work-up incl. radiological and cardiological procedures, scoring etc

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
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptomatic carotid artery disease
  • Asymptomatic carotid artery disease

排除标准

  • 未提供

结局指标

主要结局

Ischemic stroke or TIA documented by Medical record

时间窗: 3 months

次要结局

  • Any arterial event documented by Medical record (composite)(3 months)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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