Feedback Loop Between Intracranial Atherosclerosis and Cerebral Small Vessel Disease

Recruiting

• Conditions: ICAS - Intracranial Atherosclerosis; Cerebral Small Vessel Diseases
• Interventions: Diagnostic Test: Magnetic resonance imaging

• Registration Number: NCT05677607
• Lead Sponsor: Chinese PLA General Hospital

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.

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 Timeline

• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2022-12-28
• Study Start: 2023-01-01
• Study First Posted: 2023-01-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-30
• Last Update Posted: 2024-07-03
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intracranial atherosclerosis and small vessel disease	Magnetic resonance imaging	Patients diagnosed with intracranial large artery atherosclerosis and cerebral small vessel disease based on imaging screening.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China