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Imaging the Pathogenesis of Cerebral Small Vessel Disease

Imaging the Pathogenesis of Cerebral Small Vessel Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05703386
Enrollment
50
Registered
2023-01-30
Start date
2022-11-08
Completion date
2027-03-31
Last updated
2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hyperlipidemias, Hypertension, Ischemic Stroke

Keywords

Cerebral small vessel disease, Vascular cognitive impairment and dementia, White matter hyperintensities, Blood-brain barrier, Vascular risk factors, Ischemic stroke

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

Interventions

None listed

Sponsors

Johns Hopkins University
Lead SponsorOTHER
National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Progression of cerebral small vessel disease1 yearConversion of normal appearing white matter to white matter hyperintensity measured on MRI using 3D FLAIR imaging.

Countries

United States

Contacts

CONTACTSera Chase
schase15@jh.edu410-502-5355
PRINCIPAL_INVESTIGATORRichard Leigh, MD

Johns Hopkins University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026