NCT06116630 · Stanford University
StrokeCog-BBB to Study Cognitive Outcomes Following Stroke
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
DCE-MRI
Both groups will undergo DCE-MRIs.
Primary outcome measures
Correlation of leaky blood vessels in the brain and cognitive scores
Time frame: 4 years
Patients will undergo MRI imaging and cognitive testing. Amount of leakage in the blood vessels with be quantified. Scores on the cognitive tests will be normalized with Z scores. The amount of leakage and the z scores will be correlated to better understand the relationship between blood brain barrier leakage and cognition.
Correlation of blood biomarkers and cognitive scores
Time frame: 4 years
Blood will be drawn and analyzed for biomarkers, and the biomarkers concentration will be correlated with the z scores from their cognitive tests.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Palo Alto, California
Collaborators
University of Manchester, Columbia University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 18, 2024 · Source of record for eligibility and locations