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NCT Number: NCT05897645

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

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.

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Key information

Conditions

Stroke Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders High Resolution Magnetic Resonance Imaging Intracranial Arterial Diseases Intracranial Arteriosclerosis Intracranial Atherosclerosis Nervous System Diseases Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Location status: Recruiting

Location contact

Hui-Sheng Chen, Ph.D.

CONTACT

[email protected]

+86 13352452086

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Registration

Other

collect clinical date, assess the morphologic characteristics of plaque

Primary outcomes

  1. Recurrence of stroke

    Time frame: 360 days

    including ischemic or hemorrhagic stroke

Secondary outcomes

  1. Recurrence of stroke

    Time frame: 90 days, 180 days

    including ischemic or hemorrhagic stroke

  2. the composite events of cardiovascular events

    Time frame: 90 days, 180 days, 360 days

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

  3. distribution of modified Rankin Scale (mRS) score

    Time frame: 90 days, 180 days 360 days

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

  4. The relationship between characteristics of intracranial plaques and functional independence

    Time frame: 90 days, 180 days, 360 days

    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])

  5. The relationship between burden of cerebral small vessel disease and functional independence

    Time frame: 90 days, 180 days, 360 days

    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])

Study contacts

Contact information is provided by the study sponsor or research team.

HuiSheng

CONTACT

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

High-resolution Magnetic Resonance Imaging of Intracranial Atherosclerotic Plaques in Ischemic Stroke (HRMRI-ICAS): a Prospective, Multicenter Cohort Study

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2023
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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