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

NCT05897645 | Recruiting

• 1 other identifier: Y(2022)070
• Study Type: observational
• Target: 2,110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Intracranial Atherosclerosis; High Resolution Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Recurrence of stroke

  including ischemic or hemorrhagic stroke

  360 days

Secondary Outcomes (5)

• Recurrence of stroke

  90 days, 180 days

• the composite events of cardiovascular events

  90 days, 180 days, 360 days

• distribution of modified Rankin Scale (mRS) score

  90 days, 180 days 360 days

• The relationship between characteristics of intracranial plaques and functional independence

  90 days, 180 days, 360 days

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

  90 days, 180 days, 360 days

Interventions

Registration OTHER

collect clinical date, assess the morphologic characteristics of plaque

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with ischemic stroke who performed HRMRI

You may qualify if:

• \. Patient age ≥40 years
• \. Time of stroke onset: within 2 week
• \. Baseline NIHSS score ≤16
• \. Ischemic stroke confirmed by head CT or MRI
• \. Premorbid mRS ≤1
• \. The degree of stenosis of extracranial arteries including internal carotid artery, vertebral artery on the lesion side ≤50%
• \. 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
• \. Signed informed consent

You may not qualify if:

• \. Intracranial hemorrhage found by head CT
• \. Had a contraindication to MRI,or could not complete required MRI sequences
• \. Intracranial tumor, arteriovenous malformation, or aneurysm
• \. Comorbidity with any serious diseases and life expectancy is less than one year
• \. Pregnancy
• \. Patients not suitable for this clinical studies considered by researcher

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

RECRUITING

MeSH Terms

Conditions

Stroke; Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• HuiSheng Chen

  General Hospital of Northern Theatre Command

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HuiSheng

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 9, 2023
• Study Start: January 19, 2023
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

CN (1)