Imaging the Pathogenesis of Cerebral Small Vessel Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke, Hypertension, Hyperlipidemias, Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Primary outcome measures
- Progression of cerebral small vessel disease [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Kennedy Krieger Institute — Baltimore
Identifiers
NCT: NCT05703386 · IRB00313202