Imaging the Pathogenesis of Cerebral Small Vessel Disease

Recruiting

• Conditions: Hypertension; Ischemic Stroke; Hyperlipidemias; Diabetes

• Registration Number: NCT05703386
• Lead Sponsor: Johns Hopkins University

Brief Summary

Cerebral small vessel disease (CSVD) can lead to vascular cognitive impairment and dementia (VCID). The hallmark of CSVD is the appearance and progression of white matter hyperintensities (WMH) on MRI. The goal of this study it to recruit and follow individuals at risk for WMH progression and use serial MRI scanning to gain insights into the pathogenesis of CSVD.

Detailed Description

Vascular Cognitive Impairment and Dementia (VCID) which is attributed in large part to cerebral small vessel disease (CSVD) is prevalent in patients with a history of stroke and vascular risk factors. The hallmark of CSVD is white matter hyperintensities (WMH) seen on T2-weighted MRI. The initial amount, and rate of progression, of WMH is tied closely with the development and progression cognitive deficits. It is hypothesized that one of the early pathologic features in the normal appearing white matter (NAWM), before it progresses to WMH is disruption of the blood-brain barrier (BBB) and loss of micro-structural integrity. The purpose of this study is track the progression of WMH using multiple MRI biomarkers looking at BBB disruption (DCE, DSC, ASL), micro-structural changes (multi-shell DTI), and macrostructural changes (FLAIR, SWI, T1) to better understand the pathogenesis of CSVD. Patients with a history of a stroke, at least one vascular risk factor, and evidence of CSVD on MRI may be eligible for this study. We will follow 50 patients with 3 MRIs performed over 1.25 years

Study Timeline

• Study Start: 2022-11-08
• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-18
• Study First Posted: 2023-01-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Clinical or radiographic evidence of ischemic stroke
• One vascular risk factor (hypertension, hyperlipidemia, or diabetes)
• Evidence of cerebral small vessel disease on MRI

Exclusion Criteria

• Inability to complete 3 research MRI scans over 1.25 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression of cerebral small vessel disease	1 year	Conversion of normal appearing white matter to white matter hyperintensity measured on MRI using 3D FLAIR imaging.

Trial Locations

Locations (1)

Kennedy Krieger Institute; 🇺🇸 Baltimore, Maryland, United States