StrokeCog-BBB to Study Cognitive Outcomes Following Stroke

NCT06116630 | Recruiting DMC

• 1 other identifier: 63979
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Correlation of leaky blood vessels in the brain and cognitive scores

  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.

  4 years

• Correlation of blood biomarkers and cognitive scores

  Blood will be drawn and analyzed for biomarkers, and the biomarkers concentration will be correlated with the z scores from their cognitive tests.

  4 years

Study Arms (2)

Stroke

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

Diagnostic Test: DCE-MRI

Control

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

Diagnostic Test: DCE-MRI

Interventions

DCE-MRI DIAGNOSTIC_TEST

Both groups will undergo DCE-MRIs.

Control; Stroke

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be enrolled from Stanford University Hospital, which is a major urban center with a diverse patient population.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead
• University of Manchester: collaborator
• Columbia University: collaborator

Study Sites (1)

Stanford University Hospital

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Dynamic Contrast Enhanced Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Marion Buckwalter, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhith Musabbir

CONTACT

650-723-8886; musabbir@stanford.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: May 17, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)