Imaging the Pathogenesis of Cerebral Small Vessel Disease

Hypertension Clinical Trial

Official title:

Imaging the Pathogenesis of Cerebral Small Vessel Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05703386
• Other study ID #: IRB00313202
• Status: Recruiting
• Start date: November 8, 2022
• Est. completion date: March 31, 2027

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: Pooja Patel
• Phone: 410-502-5355
• Email: ppate120[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases
• Diabetes
• Hyperlipidemias
• Hypertension
• Ischemic Stroke

Locations

Country	Name	City	State
United States	Kennedy Krieger Institute	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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