Imaging the Pathogenesis of Cerebral Small Vessel Disease

NCT ID: NCT05703386

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-08

Study Completion Date

2027-03-31

Brief Summary

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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

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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

Conditions

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Ischemic Stroke Hypertension Hyperlipidemias Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Leigh, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Kennedy Krieger Institute

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sera Chase

Role: CONTACT

410-502-5355

Facility Contacts

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Pooja Patel

Role: primary

410-502-5355

Other Identifiers

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IRB00313202

Identifier Type: -

Identifier Source: org_study_id

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