Imaging the Pathogenesis of Cerebral Small Vessel Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Diabetes; Ischemic Stroke; Hyperlipidemias

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Pooja Patel; Phone Number: 410-502-5355; Email: ppate120@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Kennedy Krieger Institute
      • Contact: Pooja Patel; Phone Number: 410-502-5355; Email: ppate120@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Richard Leigh, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2022
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: January 6, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Ischemic stroke; Blood-brain barrier; Cerebral small vessel disease; Vascular risk factors; Vascular cognitive impairment and dementia; White matter hyperintensities
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Lipid Metabolism Disorders; Dyslipidemias; Stroke; Ischemic Stroke; Hyperlipidemias; Cerebral Small Vessel Diseases
• Other Study ID Numbers: IRB00313202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No