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Clinical Trials/NCT05213793
NCT05213793
Recruiting
Not Applicable

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

Xuanwu Hospital, Beijing1 site in 1 country200 target enrollmentApril 1, 2021
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Xuanwu Hospital, Beijing
Enrollment
200
Locations
1
Primary Endpoint
Compare the volume of reversible ischemic injury of brain tissue measured by multi-delay ASL versus CTP
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
December 31, 2025
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

qingfengma

MD

Xuanwu Hospital, Beijing

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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,

Secondary Outcomes

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

Study Sites (1)

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