StrokeNCT05213793
Multi-delay Arterial Spin Labeling Application in Acute Ischemic Stroke
An observational study of Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- multi-delay arterial spin labeling
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute anterior circulation ischemic stroke without contraindication to MRI will be enrolled.
Who may be able to join
- Ischemic stroke within 24h；
- Anterior circulation occlusion confirmed by conventional angiography or magnetic resonance angiography；
Who cannot join
- Pregnancy and other contraindication to MRI scan；
- Informed consent not obtained.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital
Beijing, Beijing Municipality, 100053
qingfeng Ma, +8613601069493, m.qingfeng@163.com
About this study
Official title: 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.
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.
- Conditions
- Stroke
- Being tested
- multi-delay arterial spin labeling
- Keywords
- Ischemic Stroke, Magnetic Resonance Imaging, Cerebrovascular Disease
- Medical subject headings
- Stroke, Ischemic Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-delay arterial spin labelingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: multi-delay arterial spin labeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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.
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Apr 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, qingfengma, Xuanwu Hospital, Beijing
- Investigators
- qingfeng Ma, MD, Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213793
- Sponsor's protocol ID
- qingfeng ma ASL XuanwuH
- Status last verified
- Jan 2022
- First submitted
- 15 Jan 2022
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 24302482Wang 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of a Noninvasive Quantitative Assessment System for Cerebral Perfusion Function in the "Green Channel" of Acute Stroke
- ClinicalTrials.gov ID
- NCT05213793
- Acronym / sponsor ID
- qingfeng ma ASL XuanwuH
- Conditions
- Stroke
- Keywords
- Ischemic Stroke, Magnetic Resonance Imaging, Cerebrovascular Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ischemic stroke | – | Diagnostic Test: multi-delay arterial spin labelingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute anterior circulation ischemic stroke without contraindication to MRI will be enrolled.
Key inclusion criteria (2 listed)
- Ischemic stroke within 24h；
- Anterior circulation occlusion confirmed by conventional angiography or magnetic resonance angiography；
Key exclusion criteria (2 listed)
- Pregnancy and other contraindication to MRI scan；
- Informed consent not obtained.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi-delay arterial spin labelingMulti-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. | Diagnostic test | ischemic stroke |
Primary outcome
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,
1 secondary outcome
The difference of the procedure of CTP and multi-delay ASL
Time frame: 24hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Background: PubMed 24302482Bivard 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.
- Background: PubMed 24159561Wang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
qingfeng Ma, MD study chair
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact qingfeng Ma, MD (+8613601069493, m.qingfeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the volume of reversible ischemic injury of brain tissue measured by multi-delay ASL versus CTP (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05213793, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022; AzTrials last refreshed its copy on 30 Oct 2026.