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Recruiting NCT05897645

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

— Observational Stroke Intracranial Atherosclerosis High Resolution Magnetic Resonance Imaging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Registration.
Who it may be relevant to
Registry conditions: Stroke, Intracranial Atherosclerosis, High Resolution Magnetic Resonance Imaging. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Registration
    collect clinical date, assess the morphologic characteristics of plaque

Primary outcome measures

  • Recurrence of stroke [Time frame: 360 days]
Secondary outcome measures (5)
  • Recurrence of stroke [Time frame: 90 days, 180 days]
  • the composite events of cardiovascular events [Time frame: 90 days, 180 days, 360 days]
  • distribution of modified Rankin Scale (mRS) score [Time frame: 90 days, 180 days 360 days]
  • The relationship between characteristics of intracranial plaques and functional independence [Time frame: 90 days, 180 days, 360 days]
  • The relationship between burden of cerebral small vessel disease and functional independence [Time frame: 90 days, 180 days, 360 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Department of Neurology, General Hospital of Northern Theater Command — Shenyang

Identifiers

NCT: NCT05897645 · Y(2022)070

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗