NCT05703386

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
10mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Nov 2022Mar 2027

Study Start

First participant enrolled

November 8, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

4.4 years

First QC Date

January 6, 2023

Last Update Submit

March 2, 2026

Conditions

Ischemic StrokeHypertensionHyperlipidemiasDiabetes

Keywords

Cerebral small vessel diseaseVascular cognitive impairment and dementiaWhite matter hyperintensitiesBlood-brain barrierVascular risk factorsIschemic stroke

Outcome Measures

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.

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Clinical or radiographic evidence of ischemic stroke
  • One vascular risk factor (hypertension, hyperlipidemia, or diabetes)
  • Evidence of cerebral small vessel disease on MRI

You may not qualify if:

  • Inability to complete 3 research MRI scans over 1.25 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeHypertensionHyperlipidemiasDiabetes MellitusCerebral Small Vessel DiseasesDementia

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Richard Leigh, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sera Chase

CONTACT

410-502-5355schase15@jh.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2023

First Posted

January 30, 2023

Study Start

November 8, 2022

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

March 3, 2026

Record last verified: 2026-03

Locations

US(1)