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RecruitingNCT05213793Updated Jan 28, 2022

Multi-delay Arterial Spin Labeling Application in Acute Ischemic Stroke

An observational study in Stroke, sponsored by Xuanwu Hospital, Beijing. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-28.

Sponsored by Xuanwu Hospital, Beijing · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2022, 3 years 9 months ago, but the record still lists the study as recruiting.
  • Started Apr 2021; still recruiting 5 years 6 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke

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Keywords

  • Ischemic Stroke
  • Magnetic Resonance Imaging
  • Cerebrovascular Disease
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 200 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with acute anterior circulation ischemic stroke without contraindication to MRI will be enrolled.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy and other contraindication to MRI scan;
  2. Informed consent not obtained.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • ischemic stroke

    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.

    Diagnostic Test: multi-delay arterial spin labeling

Interventions

  • Diagnostic testmulti-delay arterial spin labeling

    Multi-delay arterial spin labeling is a new method to evaluate the degree of the cerebral perfusion. It can obtain three parameters including CBF,CBV and ATT without radiation,which is similar to the traditional technology. Multi-delay ASL can provide more information of the acute stroke patients.

06

What researchers measure

Primary outcomes

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

    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,

    Time frame: 24 hours

Secondary outcomes

  1. The difference of the procedure of CTP and multi-delay ASL

    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.

    Time frame: 24hours

07

Study locations

1 of 1 sites recruiting
  • Xuanwu Hospital
    Beijing, Beijing 100053, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 24302482 ↗
  • 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. PubMed 24159561 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05213793
Lead sponsor
Xuanwu Hospital, Beijing
Responsible party
qingfengma (MD, Xuanwu Hospital, Beijing) — Principal investigator
First posted
Jan 28, 2022
Start date
Apr 1, 2021
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jan 28, 2022

Study contacts

qingfeng Ma, MD
Contact
m.qingfeng@163.com
+8613601069493
chuming Yan, MBBS
Contact
ycm19960214@163.com
+8618810673782
qingfeng Ma, MD
study chair · Xuanwu Hospital, Beijing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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