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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Intracranial Atherosclerosis; High Resolution Magnetic Resonance Imaging
• Intervention / Treatment: Other: Registration

• Study Type: Observational
• Enrollment (Estimated): 2110

Contacts and Locations

• Study Contact: Name: HuiSheng

Study Locations

• China
  • Shenyang, China, 110016
    • Recruiting
    • Department of Neurology, General Hospital of Northern Theater Command
    • Contact: Hui-Sheng Chen, Ph.D.; Phone Number: +86 13352452086; Email: chszh@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients with ischemic stroke who performed HRMRI

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of stroke	including ischemic or hemorrhagic stroke	360 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence of stroke	including ischemic or hemorrhagic stroke	90 days, 180 days
the composite events of cardiovascular events	Cardiovascular events include cardiovascular death, stroke, non-fatal myocardial infarction, and arterial revascularization	90 days, 180 days, 360 days
distribution of modified Rankin Scale (mRS) score	mRS score range from 0 to 6: 0 [no symptoms] to 6 [death]	90 days, 180 days 360 days
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])	90 days, 180 days, 360 days
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])	90 days, 180 days, 360 days

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region
• Investigators: Principal Investigator: HuiSheng Chen, General Hospital of Northern Theatre Command

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Intracranial Arterial Diseases; Stroke; Ischemic Stroke; Atherosclerosis; Plaque, Atherosclerotic; Intracranial Arteriosclerosis
• Other Study ID Numbers: Y(2022)070

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No