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

Sponsor
General Hospital of Shenyang Military Region (Other)
Overall Status
Recruiting
CT.gov ID
NCT05897645
Collaborator
(none)
2,110
Enrollment
1
Location
35.4
Anticipated Duration (Months)
59.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Registration

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
2110 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
High-resolution Magnetic Resonance Imaging of Intracranial Atherosclerotic Plaques in Ischemic Stroke (HRMRI-ICAS): a Prospective, Multicenter Cohort Study
Actual Study Start Date :
Jan 19, 2023
Anticipated Primary Completion Date :
Jan 1, 2026
Anticipated Study Completion Date :
Jan 1, 2026

Outcome Measures

Primary Outcome Measures

  1. Recurrence of stroke [360 days]

    including ischemic or hemorrhagic stroke

Secondary Outcome Measures

  1. Recurrence of stroke [90 days, 180 days]

    including ischemic or hemorrhagic stroke

  2. the composite events of cardiovascular events [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 [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 [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 [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])

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Patient age ≥40 years
    1. Time of stroke onset: within 2 week
    1. Baseline NIHSS score ≤16
    1. Ischemic stroke confirmed by head CT or MRI
    1. Premorbid mRS ≤1
    1. The degree of stenosis of extracranial arteries including internal carotid artery, vertebral artery on the lesion side ≤50%
    1. 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
    1. Signed informed consent
Exclusion Criteria:
    1. Intracranial hemorrhage found by head CT
    1. Had a contraindication to MRI,or could not complete required MRI sequences
    1. Intracranial tumor, arteriovenous malformation, or aneurysm
    1. Comorbidity with any serious diseases and life expectancy is less than one year
    1. Pregnancy
    1. Patients not suitable for this clinical studies considered by researcher

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Neurology, General Hospital of Northern Theater Command Shenyang China 110016

Sponsors and Collaborators

  • General Hospital of Shenyang Military Region

Investigators

  • Principal Investigator: HuiSheng Chen, General Hospital of Northern Theatre Command

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hui-Sheng Chen, chief, General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier:
NCT05897645
Other Study ID Numbers:
  • Y(2022)070
First Posted:
Jun 9, 2023
Last Update Posted:
Jun 9, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stroke
Ischemic Stroke
Intracranial Arteriosclerosis
Atherosclerosis
Plaque, Atherosclerotic

Study Results

No Results Posted as of Jun 9, 2023