The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05703386
Recruitment Status : **RECRUITING NOW**
First Posted : January 30, 2023
Last Update Posted : January 30, 2023
Sponsor:
Information provided by (Responsible Party):
Richard Leigh, Johns Hopkins University
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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.
Ischemic Stroke Hypertension Hyperlipidemias Diabetes
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
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Study Type :
Observational
Estimated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Imaging the Pathogenesis of Cerebral Small Vessel Disease
Actual Study Start Date :
November 8, 2022
Estimated Primary Completion Date :
March 31, 2027
Estimated Study Completion Date :
March 31, 2027
Resource links provided by the National Library of Medicine
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Primary Outcome Measures :
Progression of cerebral small vessel disease [ Time Frame: 1 year ]
Conversion of normal appearing white matter to white matter hyperintensity measured on MRI using 3D FLAIR imaging.
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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Ages Eligible for Study: Â
18 Years and older  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Sampling Method: Â
Non-Probability Sample
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.
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
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05703386
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Contact: Pooja Patel
410-502-5355
ppate120@jhmi.edu
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Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
Contact: Pooja Patel   410-502-5355   ppate120@jhmi.edu  Â
Johns Hopkins University
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Principal Investigator:
Richard Leigh, MD
Johns Hopkins University
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Responsible Party:
Richard Leigh, Associate Professor of Neurology, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT05703386 Â Â
Other Study ID Numbers:
IRB00313202
First Posted:
January 30, 2023 Â Â Key Record Dates
Last Update Posted:
January 30, 2023
Last Verified:
January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Undecided
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Richard Leigh, Johns Hopkins University:
Cerebral small vessel diseaseVascular cognitive impairment and dementiaWhite matter hyperintensities
Blood-brain barrierVascular risk factorsIschemic stroke
Additional relevant MeSH terms:
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Cardiovascular DiseasesIschemic StrokeCerebral Small Vessel DiseasesHyperlipidemiasStrokeCerebrovascular DisordersBrain Diseases
Central Nervous System DiseasesNervous System DiseasesVascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
