Magnetic Resonance Imaging in Cerebral Small Vessel Disease

Recruiting

• Conditions: Cerebral Small Vessel Diseases; MRI
• Interventions: Diagnostic Test: Magnetic resonance imaging

• Registration Number: NCT05200377
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

Cerebral small vessel disease (cSVD) accounts for 20% of ischemic strokes and is the most common cause of vascular cognitive impairment. Early identification of cSVD is critical for early intervention and improve clinical outcomes. Magnetic resonance imaging (MRI) may represent as a sensitive and robust tool to detect early changes in brain subtle structures and functions. The study is to investigate the comprehensive evaluation of brain structures and vascular functions by using advanced MRI technologies in early diagnosis and management of cSVD.

Detailed Description

Cerebral small vessel disease (cSVD) accounts for 20% of ischemic strokes and is the most common cause of vascular cognitive impairment. Early identification of cSVD is critical for early intervention and improve clinical outcomes. Magnetic resonance imaging (MRI) is sensitive to change in white matter structure and subtle vascular function alternation which correlates with cognition impairments in cSVD. MRI manifestation may also represent as useful surrogate marker. Development of advanced MRI technologies promotes their invaluable application in brain and vascular qualitative and quantitative assessment. The study is to investigate the comprehensive evaluation of brain structures and vascular functions by using advanced MRI technologies in early diagnosis and management of cSVD.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-01-06
• Study First Posted: 2022-01-20
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

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

Inclusion Criteria

• Clinical evidence of cerebral small vessel disease or MRI evidence of lacunar infarcts and white matter hyperintensity
• No disability (modified Rankin's scale < 2)
• No dementia (MMSE > 24 and absence of dependence in daily activities)
• Able and willing to consent

Exclusion Criteria

• Contraindications to MRI
• Standard MRI of bad quality due to movement artefacts
• Pregnant
• Unable to tolerate MRI

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cerebral small vessel disease group	Magnetic resonance imaging	Patients with clinically and radiologically evidenced cerebral small vessel disease. Patients are grouped by severity of cerebral small vessel disease assessed by comprehensive MRI findings.

Primary Outcome Measures

Name	Time	Method
Progression in total cerebral small vessel disease burden	1 year	Total cSVD burden assessed by MRI

Secondary Outcome Measures

Name	Time	Method
Progression in congnitive impairments	1 years	Global Z-score by cognitive domain
Modified Rankin Scale	90 days and 1 year after qualifying event	Disability assessed by modified Rankin Scale (mRS). The scores, ranging from 0 (no symptoms) to 6 (death), were recorded by phone call or outpatient consultation. A favorable outcome was defined as mRS score 0-2, unfavorable outcome was defined as mRS score \> 2.
Recurrent ischemic events	1 year	Recurrent ischemic stroke, TIA and vascular death

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, China