Recruiting

StrokeCog-BBB

Sponsor:

Stanford University

Code:

NCT06116630

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

DCE-MRI

Study Details

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.

Conditions

Stroke

Study ID

NCT06116630

Start date

May 17, 2022

Status verified date

Apr, 2024

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

350 participants

Anticipated

Interventions and Outcome Measures

Arms

Stroke

Patients who have a history of stroke will be in the first group.

Control

Patients who do not have a history of stroke, but have a history of cardiovascular risk factors will be in the second group.

Interventions

DCE-MRI

Both groups will undergo DCE-MRIs.

Primary outcome measure

  • Correlation of leaky blood vessels in the brain and cognitive scores [ Time Frame: 4 years ]
  • Correlation of blood biomarkers and cognitive scores [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Muhith Musabbir

650-723-8886musabbir@stanford.edu

Locations

Stanford University Hospital

Recruiting

Palo Alto, California, United States, 94304

Contacts

Muhith Musabbir

650-723-8886

More Information

Sponsor

Stanford University

Last update posted

Apr 18, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2024-04-18.