Ischemic StrokeNCT05556395
Global Blood-Brain Barrier Disruption and Post-Stroke Cognitive Decline
An observational study of Ischemic Stroke, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of this study is to gain a better understanding of why some individuals who have suffered a stroke experience post-stroke cognitive decline. Specifically this study is testing whether global disruption of the blood-brain barrier detected at the time of the stroke is informative about the risk of post-stroke… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 1 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are admitted to the hospital and diagnosed with an ischemic stroke based on an MRI scan that also includes perfusion imaging with an exogenous contrast agent and are will/able to be contacted for serial phone-based cognitive evaluations.
Who may be able to join
- Acute ischemic stroke demonstrated on an MRI scan that includes perfusion imaging with an exogenous contrast agent
Who cannot join
- Inability to perform telephone-based cognitive assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Diane Echavarria, 410-502-5355, dechava1@jhu.edu
About this study
The goal of this study is to gain a better understanding of why some individuals who have suffered a stroke experience post-stroke cognitive decline. Specifically this study is testing whether global disruption of the blood-brain barrier detected at the time of the stroke is informative about the risk of post-stroke cognitive decline over the next 3 years.
Read the detailed description
It is well known that ischemic stroke is a risk factor for developing dementia. Prior studies have shown that after a stroke, there can be a change in the trajectory of cognitive performance with acceleration of decline. The mechanism of this phenomenon has not been established. It is known that vascular changes in the brain, referred to as cerebral small vessel disease, are associated with cognitive decline and dementia. Cerebral small vessel disease is readily seen on MRI scans of the brain, and the larger the burden of these findings, the higher the risk of cognitive deficits. Disruption of the blood-brain barrier has been implicated in the development of the changes seen on MRI. Acute stroke has been shown to disrupt the blood-brain barrier, even in parts of the brain not directly affect by the stroke. The investigators hypothesize that when there is diffuse blood-brain barrier disruption in response to an acute stroke it sets off a cascade of changes in the brain that lead to post-stroke cognitive decline.
- Conditions
- Ischemic Stroke
- Keywords
- blood-brain barrier, post-stroke cognitive impairment and dementia, vascular cognitive impairment and dementia, Alzheimer's disease and related dementias, stroke
- Medical subject headings
- Ischemic Stroke, Dementia, Alzheimer Disease, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognition (Cognitive Decline)
Serial telephone-based cognitive assessments will be performed to detect cognitive changes (cognitive decline).
Measured: Assessments occur every 6 months for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Apr 2022
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Leigh, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556395
- Sponsor's protocol ID
- IRB00312030
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2022
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Blood-Brain Barrier Disruption and Post-Stroke Cognitive Decline
- ClinicalTrials.gov ID
- NCT05556395
- Acronym / sponsor ID
- IRB00312030
- Conditions
- Ischemic Stroke
- Keywords
- blood-brain barrier, post-stroke cognitive impairment and dementia, vascular cognitive impairment and dementia, Alzheimer's disease and related dementias, stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to gain a better understanding of why some individuals who have suffered a stroke experience post-stroke cognitive decline. Specifically this study is testing whether global disruption of the blood-brain barrier detected at the time of the stroke is informative about the risk of post-stroke cognitive decline over the next 3 years.
Detailed description
It is well known that ischemic stroke is a risk factor for developing dementia. Prior studies have shown that after a stroke, there can be a change in the trajectory of cognitive performance with acceleration of decline. The mechanism of this phenomenon has not been established. It is known that vascular changes in the brain, referred to as cerebral small vessel disease, are associated with cognitive decline and dementia. Cerebral small vessel disease is readily seen on MRI scans of the brain, and the larger the burden of these findings, the higher the risk of cognitive deficits. Disruption of the blood-brain barrier has been implicated in the development of the changes seen on MRI. Acute stroke has been shown to disrupt the blood-brain barrier, even in parts of the brain not directly affect by the stroke. The investigators hypothesize that when there is diffuse blood-brain barrier disruption in response to an acute stroke it sets off a cascade of changes in the brain that lead to post-stroke cognitive decline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are admitted to the hospital and diagnosed with an ischemic stroke based on an MRI scan that also includes perfusion imaging with an exogenous contrast agent and are will/able to be contacted for serial phone-based cognitive evaluations.
Key inclusion criteria (1 listed)
- Acute ischemic stroke demonstrated on an MRI scan that includes perfusion imaging with an exogenous contrast agent
Key exclusion criteria (1 listed)
- Inability to perform telephone-based cognitive assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Cognition (Cognitive Decline)
Time frame: Assessments occur every 6 months for 3 years
Serial telephone-based cognitive assessments will be performed to detect cognitive changes (cognitive decline).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share IPD with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Leigh, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diane Echavarria (410 502 5355, dechava1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognition (Cognitive Decline) (time frame: Assessments occur every 6 months for 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.