Multi-delay Arterial Spin Labeling Application in Acute Ischemic Stroke

January 15, 2022 updated by: qingfengma, Xuanwu Hospital, Beijing

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xuanwu hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference of the procedure of CTP and multi-delay ASL
Time Frame: 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.
24hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuanwu Hospital, Beijing

Investigators

  • Study Chair: Qingfeng Ma, MD, Xuanwu Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

January 15, 2022

First Submitted That Met QC Criteria

January 15, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 15, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • qingfeng ma ASL XuanwuH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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