StrokeCog-BBB to Study Cognitive Outcomes Following Stroke
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.
Conditions:
🦠 Stroke
🗓️ Study Start (Actual) 17 May 2022
🗓️ Primary Completion (Estimated) 31 December 2027
✅ Study Completion (Estimated) 31 December 2027
👥 Enrollment (Estimated) 350
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Palo Alto, California, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 45 Years to 90 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 October 2023
  • First Submitted that Met QC Criteria 30 October 2023
  • First Posted 3 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 April 2024
  • Last Update Posted 18 April 2024
  • Last Verified April 2024