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NCT Number: NCT05556395

Global Blood-Brain Barrier Disruption and Post-Stroke Cognitive Decline

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location status: Recruiting

Location contact

Diane Echavarria

CONTACT

[email protected]

410-502-5355

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute ischemic stroke demonstrated on an MRI scan that includes perfusion imaging with an exogenous contrast agent

Exclusion criteria

  • Inability to perform telephone-based cognitive assessments

Treatment and study plan

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Diane Echavarria

CONTACT

[email protected]

410 502 5355

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 27, 2022
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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