StrokeNCT05897645
High-resolution Magnetic Resonance Imaging of Intracranial Atherosclerotic Plaques in Ischemic Stroke
An observational study of Stroke and Intracranial Atherosclerosis, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
Intracranial atherosclerotic disease is the most common cause of ischemic stroke in Asia, also in China. Currently, despite vascular recanalization therapy, statins are one of the main drug choices for treating atherosclerotic plaque. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke, Intracranial Atherosclerosis, High Resolution Magnetic Resonance Imaging
- What is being tested?
- Registration
- How many people
- 2,110 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2023to 30 Jan 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with ischemic stroke who performed HRMRI
Who may be able to join
- 1. Patient age ≥40 years
- 2. Time of stroke onset: within 2 week
- 3. Baseline NIHSS score ≤16
- 4. Ischemic stroke confirmed by head CT or MRI
- 5. Premorbid mRS ≤1
- 6. The degree of stenosis of extracranial arteries including internal carotid artery, vertebral artery on the lesion side ≤50%
- 7. The culprit plaque or possible culprit plaque with plaque burden of 40% or more found by HRMRI in the proximal part of the middle cerebral artery M1 segment or basilar artery of ipsilateral lesion
- 8. Signed informed consent
Who cannot join
- 1. Intracranial hemorrhage found by head CT
- 2. Had a contraindication to MRI,or could not complete required MRI sequences
- 3. Intracranial tumor, arteriovenous malformation, or aneurysm
- 4. Comorbidity with any serious diseases and life expectancy is less than one year
- 5. Pregnancy
- 6. Patients not suitable for this clinical studies considered by researcher
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
HuiSheng contact
China1 site, 1 recruiting
- Recruiting
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016
Hui-Sheng Chen, Ph.D., +86 13352452086, chszh@aliyun.com
About this study
Official title: High-resolution Magnetic Resonance Imaging of Intracranial Atherosclerotic Plaques in Ischemic Stroke (HRMRI-ICAS): a Prospective, Multicenter Cohort Study
Intracranial atherosclerotic disease is the most common cause of ischemic stroke in Asia, also in China. Currently, despite vascular recanalization therapy, statins are one of the main drug choices for treating atherosclerotic plaque. High resolution magnetic resonance imaging (HRMRI) can accurately assess the status of intracranial and extracranial arterial plaque, and has high consistency with histopathology. Thus, HRMRI technology has been widely used to monitor the efficacy of drug treatment for atherosclerotic plaque in clinical trials or practice.
As a non-invasive technique, HRMRI make it possible to assess the morphologic characteristics of vascular wall and plaque composition of intracranial artery in vivo. It can quantitative analysis including components such as lipid-rich necrotic core, fiber cap thickness, intra-plaque hemorrhage, calcification, etc. Therefore, it is crucial for evaluating the etiology of ischemic stroke and developing secondary prevention strategies.
At present, there is a lack of large-scale and prospective study to evaluate the etiology of ischemic stroke including cryptogenic stroke based on HRMRI. In this context, this study aims to establish a multi center HRMRI database of intracranial arteries among Chinese patients with ischemic stroke.
- Being tested
- Registration
- Medical subject headings
- Stroke, Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistrationOther
collect clinical date, assess the morphologic characteristics of plaque
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of stroke
including ischemic or hemorrhagic stroke
Measured: 360 days
Secondary outcomes (5)
Recurrence of stroke
including ischemic or hemorrhagic stroke
Measured: 90 days, 180 days
the composite events of cardiovascular events
Cardiovascular events include cardiovascular death, stroke, non-fatal myocardial infarction, and arterial revascularization
Measured: 90 days, 180 days, 360 days
distribution of modified Rankin Scale (mRS) score
mRS score range from 0 to 6: 0 [no symptoms] to 6 [death]
Measured: 90 days, 180 days 360 days
The relationship between characteristics of intracranial plaques and functional independence
characteristics of intracranial plaques includes plaque composition, location and morphology; functional independence is defined as modified Rankin Scale (mRS) score 0-1 (mRS score range from 0 to 6: 0 [no symptoms] to 6 [death])
Measured: 90 days, 180 days, 360 days
The relationship between burden of cerebral small vessel disease and functional independence
burden of cerebral small vessel disease ranges from 0 to 4, with higher scores indicating greater burden; functional independence is defined as modified Rankin Scale (mRS) score 0-1 (mRS score range from 0 to 6: 0 [no symptoms] to 6 [death])
Measured: 90 days, 180 days, 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start19 Jan 2023
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,110 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
- Investigators
- HuiSheng Chen, Principal investigator, General Hospital of Northern Theatre Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897645
- Sponsor's protocol ID
- Y(2022)070
- Status last verified
- Sep 2026
- First submitted
- 23 May 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-resolution Magnetic Resonance Imaging of Intracranial Atherosclerotic Plaques in Ischemic Stroke (HRMRI-ICAS): a Prospective, Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT05897645
- Acronym / sponsor ID
- Y(2022)070
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,110 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 9 Jun 2023 (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.
Intracranial atherosclerotic disease is the most common cause of ischemic stroke in Asia, also in China. Currently, despite vascular recanalization therapy, statins are one of the main drug choices for treating atherosclerotic plaque. High resolution magnetic resonance imaging (HRMRI) can accurately assess the status of intracranial and extracranial arterial plaque, and has high consistency with histopathology. Thus, HRMRI technology has been widely used to monitor the efficacy of drug treatment for atherosclerotic plaque in clinical trials or practice.
As a non-invasive technique, HRMRI make it possible to assess the morphologic characteristics of vascular wall and plaque composition of intracranial artery in vivo. It can quantitative analysis including components such as lipid-rich necrotic core, fiber cap thickness, intra-plaque hemorrhage, calcification, etc. Therefore, it is crucial for evaluating the etiology of ischemic stroke and developing secondary prevention strategies.
At present, there is a lack of large-scale and prospective study to evaluate the etiology of ischemic stroke including cryptogenic stroke based on HRMRI. In this context, this study aims to establish a multi center HRMRI database of intracranial arteries among Chinese patients with ischemic stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with ischemic stroke who performed HRMRI
Key inclusion criteria (8 listed)
- 1. Patient age ≥40 years
- 2. Time of stroke onset: within 2 week
- 3. Baseline NIHSS score ≤16
- 4. Ischemic stroke confirmed by head CT or MRI
- 5. Premorbid mRS ≤1
Key exclusion criteria (6 listed)
- 1. Intracranial hemorrhage found by head CT
- 2. Had a contraindication to MRI,or could not complete required MRI sequences
- 3. Intracranial tumor, arteriovenous malformation, or aneurysm
- 4. Comorbidity with any serious diseases and life expectancy is less than one year
- 5. Pregnancy
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 |
|---|---|---|
| Registrationcollect clinical date, assess the morphologic characteristics of plaque | Other | – |
Primary outcome
Recurrence of stroke
Time frame: 360 days
including ischemic or hemorrhagic stroke
5 secondary outcomes
Recurrence of stroke
Time frame: 90 days, 180 days
the composite events of cardiovascular events
Time frame: 90 days, 180 days, 360 days
distribution of modified Rankin Scale (mRS) score
Time frame: 90 days, 180 days 360 days
The relationship between characteristics of intracranial plaques and functional independence
Time frame: 90 days, 180 days, 360 days
The relationship between burden of cerebral small vessel disease and functional independence
Time frame: 90 days, 180 days, 360 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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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.
HuiSheng contact
HuiSheng Chen principal investigator
General Hospital of Northern Theatre Command
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 and Intracranial Atherosclerosis, run by General Hospital of Shenyang Military Region 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HuiSheng, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of stroke (time frame: 360 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2026.