Clinical trial NCT05213793: Multi-delay Arterial Spin Labeling Application in Acute Ischemic Stroke
Official title: Application of a Noninvasive Quantitative Assessment System for Cerebral Perfusion Function in the "Green Channel" of Acute Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: Ischemic Stroke
Magnetic Resonance Imaging
Cerebrovascular Disease
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute anterior circulation ischemic stroke without contraindication to MRI will be enrolled.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compare the volume of reversible ischemic injury of brain tissue measured by multi-delay ASL versus CTP
timeFrame: 24 hours
Secondary outcomes:
measure: The difference of the procedure of CTP and multi-delay ASL
timeFrame: 24hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: qingfeng Ma, MD
role: STUDY_CHAIR
References:
citation: Bivard A, Krishnamurthy V, Stanwell P, Levi C, Spratt NJ, Davis S, Parsons M. Arterial spin labeling versus bolus-tracking perfusion in hyperacute stroke. Stroke. 2014 Jan;45(1):127-33. doi: 10.1161/STROKEAHA.113.003218. Epub 2013 Dec 3.
citation: Wang DJ, Alger JR, Qiao JX, Gunther M, Pope WB, Saver JL, Salamon N, Liebeskind DS; UCLA Stroke Investigators. Multi-delay multi-parametric arterial spin-labeled perfusion MRI in acute ischemic stroke - Comparison with dynamic susceptibility contrast enhanced perfusion imaging. Neuroimage Clin. 2013 Jul 6;3:1-7. doi: 10.1016/j.nicl.2013.06.017. eCollection 2013.