Imaging the Pathogenesis of Cerebral Small Vessel Disease

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05703386
Collaborator
(none)
50
1
52.7
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Imaging the Pathogenesis of Cerebral Small Vessel Disease
    Actual Study Start Date :
    Nov 8, 2022
    Anticipated Primary Completion Date :
    Mar 31, 2027
    Anticipated Study Completion Date :
    Mar 31, 2027

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kennedy Krieger Institute Baltimore Maryland United States 21205

    Sponsors and Collaborators

    • Johns Hopkins University

    Investigators

    • Principal Investigator: Richard Leigh, MD, Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Richard Leigh, Associate Professor of Neurology, Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT05703386
    Other Study ID Numbers:
    • IRB00313202
    First Posted:
    Jan 30, 2023
    Last Update Posted:
    Jan 30, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Richard Leigh, Associate Professor of Neurology, Johns Hopkins University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 30, 2023