跳至主要内容
临床试验/NCT05213793
NCT05213793招募中不适用

Application of a Noninvasive Quantitative Assessment System for Cerebral Perfusion Function in the "Green Channel" of Acute Stroke

Xuanwu Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Compare the volume of reversible ischemic injury of brain tissue measured by multi-delay ASL versus CTP

研究概览

简要总结

This study explores the value of the non-invasive quantitative evaluation system for cerebral blood flow perfusion function in the diagnosis of stroke. Compared with traditional perfusion techniques, multi-delay arterial spin labeling (ASL) is validated to determine the accuracy of perfusion level, ischemic penumbra and other indexes in patients with acute ischemic stroke. The relationship between perfusion levels of mD-ASL parameters and clinical outcome is also studied.

详细描述

A total of 200 patients with acute anterior circulation ischemic stroke will be prospectively enrolled.

All patients underwent CTP, multi-delay ASL, DWI, CTA or TOF-MRA scanning. CBF, CBV, MTT and Tmax will be obtained based on CTP, and the range of reversible cerebral ischemia injury will be calculated based on DWI and CTP data. CBF, CBV and ATT images will be obtained based on the multi-delay ASL, and the calculated results of reversible cerebral ischemia injury will also be obtained.

Meanwhile, the image quality of CTP and multi-delay ASL will be evaluated. The time from the patient to the completion of imaging examination and the imaging examination time will be recorded.

Mann-whitney U test and T test can be used to compare the difference of assessment time between different test methods. Chi-square test can be used to compare the differences of image quality among different examination methods. Wilcoxon rank sum test can be used to evaluate the difference between CTP and Multi-delay ASL in terms of parameters and volume of reversible ischemic injury.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Ischemic stroke within 24h;
  • Anterior circulation occlusion confirmed by conventional angiography or magnetic resonance angiography;

排除标准

  • Pregnancy and other contraindication to MRI scan;
  • Informed consent not obtained.

结局指标

主要结局

Compare the volume of reversible ischemic injury of brain tissue measured by multi-delay ASL versus CTP

时间窗: 24 hours

Our primary aim is to determine if the diagnostic accuracy of multi-delay Arterial Spin Labeling (ASL) is as good as the diagnostic accuracy of CTP in acute ischemic stroke patient. To test if ASL in noninferior to CTP,

次要结局

  • The difference of the procedure of CTP and multi-delay ASL(24hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

qingfengma

MD

Xuanwu Hospital, Beijing

研究点 (1)

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