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NCT05556395 Clinical Trial

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

Ischemic Stroke Clinical Trial

Official title:
Global Blood-Brain Barrier Disruption and Post-Stroke Cognitive Decline

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05556395
Other study ID # IRB00312030
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date April 1, 2027

Study information
Verified date September 2023
Source Johns Hopkins University
Contact Pooja Patel
Phone 410 502 5355
Email ppate120@jhmi.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 cognitive decline over the next 3 years.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date April 1, 2027
Est. primary completion date April 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Cognition (Cognitive Decline) Serial telephone-based cognitive assessments will be performed to detect cognitive changes (cognitive decline). Assessments occur every 6 months for 3 years
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