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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

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

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

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 informed consent

Exclusion criteria

Exclusion Criteria:

  • 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
04

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

05

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

06

Study locations

1 of 1 sites recruiting
  • Department of Neurology, General Hospital of Northern Theater Command
    Shenyang, 110016, China
    Recruiting
07

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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