Feedback Loop Between Intracranial Atherosclerosis and Cerebral Small Vessel Disease

Sponsor

Chinese PLA General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05677607

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present study aims at verifying the mutual effects between intracranial large artery atherosclerosis and cerebral small vessel disease on disease progression and prognosis by magnetic resonance imaging, and providing biomarkers for the early prevention and treatment of cerebrovascular disease.

Condition or Disease	Intervention/Treatment	Phase
ICAS - Intracranial Atherosclerosis Cerebral Small Vessel Diseases	Diagnostic Test: Magnetic resonance imaging

Detailed Description

Cerebrovascular disease is the most common cause of death worldwide. There is a close link in structure and function between the intracranial large arteries and cerebral small vessels. Moreover, growing evidences have demonstrated that large artery atherosclerosis often coexists with small vessel disease, which may deteriorate the clinical outcomes of stroke and dementia. The mutual feedback mechanism between them is not fully understood. The present study focuses on the mechanism of mutual feedback between large artery atherosclerosis and cerebral small vessel disease by using magnetic resonance imaging. The study may provide biomarkers for the early prevention and treatment of cerebrovascular disease.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Feedback Loop Between Intracranial Atherosclerosis and Cerebral Small Vessel Disease

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Intracranial atherosclerosis and small vessel disease Patients diagnosed with intracranial large artery atherosclerosis and cerebral small vessel disease based on imaging screening.	Diagnostic Test: Magnetic resonance imaging Imaging diagnostics mainly based on Magnetic resonance imaging.

Arm

Intervention/Treatment

Intracranial atherosclerosis and small vessel disease

Patients diagnosed with intracranial large artery atherosclerosis and cerebral small vessel disease based on imaging screening.

Diagnostic Test: Magnetic resonance imaging

Imaging diagnostics mainly based on Magnetic resonance imaging.

Outcome Measures

Primary Outcome Measures

Progression in total cerebral small vessel disease burden [1-3 YEARS]
Total cerebral small vessel disease burden is assessed according to a sum of scores of white matter hyperintensity, cerebral microbleeds, lacunes and enlarged perivasular spaces on magnetic resonance imaging sequences.
Frequency of stroke recurrence [1-3 YEARS]
The percentage of symptomatic participants who suffer from stroke recurrence after enrollment in the territory of the targeted stenotic vessel.

Secondary Outcome Measures

Frequency of stroke of asymptomatic participants [1-3 YEARS]
The percentage of asymptomatic participants who suffer from stroke after enrollment in the territory of the targeted stenotic vessel.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years
At least one intracranial artery ≥ 50% atherosclerotic stenosis
Modified Rankin Scale < 2
Mini-mental State Examination > 24

Exclusion Criteria:

Concurrent ipsilateral extracranial artery ≥ 50% stenosis
Pregnant women
Contraindications to magnetic resonance examination (patients with pacemakers, nerve stimulators, artificial metal heart valves and other metal foreign bodies)