Multi-delay Arterial Spin Labeling Application in Acute Ischemic Stroke

Recruiting

• Conditions: Stroke
• Interventions: Diagnostic Test: multi-delay arterial spin labeling

• Registration Number: NCT05213793
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Study Timeline

• Study Start: 2021-04-01
• Status Verified: 2022-01
• Study First Submitted: 2022-01-15
• Study First Submitted QC: 2022-01-15
• Last Update Submitted: 2022-01-15
• Study First Posted: 2022-01-28
• Last Update Posted: 2022-01-28
• Primary Completion: 2022-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ischemic stroke	multi-delay arterial spin labeling	The cohort includes patients with acute stroke who underwent CTP, multi-delay ASL, DWI, CTA or TOF-MRA scanning.All patients will be examined within 24 hours of onset. CBF, CBV, MTT and Tmax cerebral blood flow parameter images of CTP will be obtained. CBF, CBV and ATT cerebral blood flow parameter images in multi-delay ASL will be obtained by the quantitative evaluation system. The volume of reversible ischemic tissue will be calculate according to CTP and multi-delay ASL respectively.

Primary Outcome Measures

Name	Time	Method
Compare the volume of reversible ischemic injury of brain tissue measured by multi-delay ASL versus CTP	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 Outcome Measures

Name	Time	Method
The difference of the procedure of CTP and multi-delay ASL	24hours	The researchers will collect the time from diagnosis to completion of imaging examination and the time of imaging examination.Then analyze the time and quality of the multi-delay ASL compared with CTP.

Trial Locations

Locations (1)

Xuanwu Hospital; 🇨🇳 Beijing, Beijing, China