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RecruitingNCT05703386Updated Mar 3, 2026

Imaging the Pathogenesis of Cerebral Small Vessel Disease

An observational study in Ischemic Stroke, Hypertension and Hyperlipidemias, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.

Sponsored by Johns Hopkins University · Observational

From the registry’s dates

  • Started Nov 2022; still recruiting 4 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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

02

Conditions studied

  • Ischemic Stroke
  • Hypertension
  • Hyperlipidemias
  • Diabetes

Keywords

  • Cerebral small vessel disease
  • Vascular cognitive impairment and dementia
  • White matter hyperintensities
  • Blood-brain barrier
  • Vascular risk factors
  • Ischemic stroke
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 50 is below the median of 300 across 771 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.

Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients who are identified as having had an ischemic stroke, have at least one vascular risk factor, have had an MRI demonstrating cerebral small vessel disease and are willing and able to come to our research facility in Baltimore for 3 MRI scans over 1.25 years.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Inability to complete 3 research MRI scans over 1.25 years
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Progression of cerebral small vessel disease

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

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2022 (actual). Primary completion is estimated for Mar 2027, 52 months after the start.

Of 394 non-industry observational studies under Ischemic Stroke, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 140. This study's planned 52 months is close to that.

Counting every sponsor, half of 436 studies reached it within 53 months; a quarter within 24 and three quarters within 127.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 6, 2023
First posted
Jan 30, 2023
StartActual
Nov 8, 2022
Primary completionEst.
Mar 31, 2027
CompletionEst.
Mar 31, 2027
Last update
Mar 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05703386
Responsible party
Sponsor
First posted
Jan 30, 2023
Start date
Nov 8, 2022
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Mar 3, 2026

Study contacts

Sera Chase
Contact
schase15@jh.edu
410-502-5355
Richard Leigh, MD
principal investigator · Johns Hopkins University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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