Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-01-01 @ 10:36 AM
Study NCT ID:
NCT05213793
Status:
RECRUITING
Last Update Posted:
2022-01-28
First Post:
2022-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-delay Arterial Spin Labeling Application in Acute Ischemic Stroke
Sponsor:
Xuanwu Hospital, Beijing
Organization:
Study Overview
Official Title:
Application of a Noninvasive Quantitative Assessment System for Cerebral Perfusion Function in the "Green Channel" of Acute Stroke
Status:
RECRUITING
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: