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NCT Number: NCT05703386

Imaging the Pathogenesis of Cerebral Small Vessel Disease

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.

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Key information

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progression of cerebral small vessel disease

    Time frame: 1 year

    Conversion of normal appearing white matter to white matter hyperintensity measured on MRI using 3D FLAIR imaging.

Study contacts

Contact information is provided by the study sponsor or research team.

Sera Chase

CONTACT

[email protected]

410-502-5355

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2023
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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