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Recruiting NCT06116630

StrokeCog-BBB to Study Cognitive Outcomes Following Stroke

Trial Parameters

Condition Stroke
Sponsor Stanford University
Study Type OBSERVATIONAL
Phase N/A
Enrollment 350
Sex ALL
Min Age 45 Years
Max Age 90 Years
Start Date 2022-05-17
Completion 2027-12-31
Interventions
DCE-MRI

Brief Summary

The goal of this observational study is to learn about cognitive outcomes in stroke patients. The main question it aims to answer are: 1. Is blood-brain barrier permeability compromised for years after stroke, 2. Is a blood biomarker of imbalanced angiogenesis dysregulated in chronic stroke and 3. Are there biomarkers that separately or together predicts cognitive decline after stroke, and are other MRI, blood, and clinical characteristics that are associated. Participants will undergo cognitive testing and MRIs two years apart. Researchers will compare cognitive outcomes in non-stroke patients who have cardiovascular risk factors to understand the effects of stroke on these outcomes.

Eligibility Criteria

Inclusion Criteria: * Aged 45 years or over * One or more vascular risk factors (e.g. high blood pressure, diabetes or vascular disease such as angina, a previous heart attack, a heart bypass or peripheral artery disease in the legs) * Established vascular disease (previous MI, angina, vascular stent in the peripheral bed) * Sufficiently fluent in written and spoken English * Living independently in the community * Willing/able to give consent to study participation. Exclusion Criteria: * Current treatment with IL-1 blockade or established immune-suppressant therapy (e.g. IL-1Ra or IL-1 antibodies), or treatment within the last 3 months * Currently participating in a clinical trial of investigation medicinal product (CTIMP) or device trial. * No history of any previous ischaemic or haemorrhagic stroke, a mini-stroke or a serious brain injury * Do not have dementia * Renovascular Disease * Major neurological disease (immune mediated, previous brain tumors)

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