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RecruitingNCT05897645Updated Sep 11, 2026

High-resolution Magnetic Resonance Imaging of Intracranial Atherosclerotic Plaques in Ischemic Stroke

An observational study in Stroke, Intracranial Atherosclerosis and High Resolution Magnetic Resonance Imaging, sponsored by General Hospital of Shenyang Military Region. Recruiting at 1 site in China. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by General Hospital of Shenyang Military Region · Observational

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,110
Ages
40 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Stroke
  • Intracranial Atherosclerosis
  • High Resolution Magnetic Resonance Imaging
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 2,110 is above the median of 152 across 1,968 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

General Hospital of Shenyang Military Region is the lead sponsor of 78 studies on the registry; 33 are open to participants now.

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

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with ischemic stroke who performed HRMRI

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 1. Intracranial hemorrhage found by head CT
  • 2. Had a to MRI,or could not complete required MRI sequences
  • 3. Intracranial tumor, arteriovenous malformation, or aneurysm
  • 4. Comorbidity with any serious diseases and is less than one year
  • 5. Pregnancy
  • 6. Patients not suitable for this clinical studies considered by researcher
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,110 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • OtherRegistration

    collect clinical date, assess the morphologic characteristics of plaque

06

What researchers measure

Primary outcomes

  1. Recurrence of stroke

    including ischemic or hemorrhagic stroke

    Time frame: 360 days

Secondary outcomes

  1. Recurrence of stroke

    including ischemic or hemorrhagic stroke

    Time frame: 90 days, 180 days

  2. the composite events of cardiovascular events

    Cardiovascular events include cardiovascular death, stroke, non-fatal myocardial infarction, and arterial revascularization

    Time frame: 90 days, 180 days, 360 days

  3. distribution of modified Rankin Scale (mRS) score

    mRS score range from 0 to 6: 0 \[no symptoms\] to 6 \[death\]

    Time frame: 90 days, 180 days 360 days

  4. 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 \[death\])

    Time frame: 90 days, 180 days, 360 days

  5. 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 \[death\])

    Time frame: 90 days, 180 days, 360 days

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2023 (actual). Primary completion is estimated for Jan 2028, 60 months after the start.

Of 835 non-industry observational studies under Stroke, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 92. This study's planned 60 months is above that.

Counting every sponsor, half of 897 studies reached it within 40 months; a quarter within 18 and three quarters within 85.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2023
First posted
Jun 9, 2023
StartActual
Jan 19, 2023
Primary completionEst.
Jan 30, 2028
CompletionEst.
Jan 30, 2028
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05897645
Lead sponsor
General Hospital of Shenyang Military Region
Responsible party
Hui-Sheng Chen (chief, General Hospital of Shenyang Military Region) — Principal investigator
First posted
Jun 9, 2023
Start date
Jan 19, 2023
Primary completion
Jan 30, 2028 (estimated)
Completion
Jan 30, 2028 (estimated)
Last update
Sep 11, 2026

Study contacts

HuiSheng
Contact
HuiSheng Chen
principal investigator · General Hospital of Northern Theatre Command

Oversight

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

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No contact was published for this record. The registry link below has the sponsor’s details.

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