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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05897645
• Other study ID #: Y(2022)070
• Status: Recruiting
• Start date: January 19, 2023
• Est. completion date: January 2026

Study information

• Verified date: June 2023
• Source: General Hospital of Shenyang Military Region
• Contact: HuiSheng
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2110
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis
• Ischemic Stroke
• Plaque, Atherosclerotic
• Stroke

Intervention

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

Locations

Country	Name	City	State
China	Department of Neurology, General Hospital of Northern Theater Command	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of stroke	including ischemic or hemorrhagic stroke	360 days
Secondary	Recurrence of stroke	including ischemic or hemorrhagic stroke	90 days, 180 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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