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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05897645
Enrollment
2110
Registered
2023-06-09
Start date
2023-01-19
Completion date
2028-01-30
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Resolution Magnetic Resonance Imaging, Intracranial Atherosclerosis, Stroke

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.

Interventions

collect clinical date, assess the morphologic characteristics of plaque

Sponsors

General Hospital of Shenyang Military Region
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence of stroke360 daysincluding ischemic or hemorrhagic stroke

Secondary

MeasureTime frameDescription
Recurrence of stroke90 days, 180 daysincluding ischemic or hemorrhagic stroke
the composite events of cardiovascular events90 days, 180 days, 360 daysCardiovascular events include cardiovascular death, stroke, non-fatal myocardial infarction, and arterial revascularization
distribution of modified Rankin Scale (mRS) score90 days, 180 days 360 daysmRS score range from 0 to 6: 0 \[no symptoms\] to 6 \[death\]
The relationship between characteristics of intracranial plaques and functional independence90 days, 180 days, 360 dayscharacteristics 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 \[death\])
The relationship between burden of cerebral small vessel disease and functional independence90 days, 180 days, 360 daysburden 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 \[death\])

Countries

China

Contacts

CONTACTHuiSheng
PRINCIPAL_INVESTIGATORHuiSheng Chen

General Hospital of Northern Theatre Command

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026