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临床试验/NCT03216369
NCT03216369Unknown不适用

Short- and Long-Term Hemodynamic Effects Revealed by Arterial Spin Labeling MRI of Carotid Endarterectomy and Carotid Artery Stenting

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年11月最近更新:
适应症

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
Ischemic Event

研究概览

简要总结

Carotid artery stenting(CAS) and endarterectomy(CEA) are both important treatment strategy for patients with ICA (internal carotid artery) stenosis. Three dimensional pseudo-continuous arterial spin labeling (pCASL) is a noninvasive perfusion imaging modality to detect reperfusion for recanalization therapy. And it provides information about absolute CBF (ml 100 g-1 tissue min-1) at the brain tissue level. The aim of the present study was to evaluate the series hemodynamic changes in patients who had conducted CAS or CEA by using 3D pseudo-continuous arterial spin labeling (pCASL) to explore the potential pattern of CBF alternation and thus to improve the prevention strategy for hyperperfusion syndrome.

详细描述

Patients:

Patients with unilateral severe internal carotid artery (ICA) stenosis of stroke eligible were enrolled who underwent CAS vs CEA.All patients underwent previous scan in 7 days before CAS and CEA and consecutive scan once per 24 hours after CAS and CEA.

Baseline characteristics of patients were recorded including age,gender, hypertension, hypercholesterolemia, diabetes melitus, smoking, obesity, qualifying stroke event.

Protocols:

MRI scan protocols T2 weighted image,T1 weighted image,diffusion weighted image(DWI),fluid-attenuated inversion recovery (FLAIR),arterial spin labeling(ASL) with Post labeling delay (PLD) of 2.0s,Territory ASL(TASL)(PLD=2.0s),3-dimensional Fast Spoiled Gradient Echo(3D-FSPGR).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • informed patient's consent for ICA stenting or endarterectomy
  • lack of contraindications to MRI
  • Symptomatic, unilateral ICA stenosis 70-99%;irrelevant stenosis <50% of contralateral ICA
  • TIA or stroke - within 360 days

排除标准

  • Intracranial hemorrhage
  • Informed consent not obtained
  • Common exclusion for MRI such as patients with claustrophobia
  • Patients with poor imaging quality(Poor imaging quality mainly defined as the image cannot be applied to future analysis on account of severe motion artifacts appeared in conventional MRI and mistakes in the MRI process by accident factors which cannot to be applied to future analysis)
  • Bilateral internal carotid artery occlusion

结局指标

主要结局

Ischemic Event

时间窗: Up to 1 year

The patients will be monitored whether they recured ischemic event including transient ischemic attack (TIA) or stroke confirmed by neurologist and diffusion-weighted image MRI.

次要结局

  • Hyperperfusion Syndrome(3 months)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xin Lou

Chief

Chinese PLA General Hospital

研究点 (1)

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