StrokeNCT06116630
StrokeCog-BBB to Study Cognitive Outcomes Following Stroke
An observational study of Stroke, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- DCE-MRI
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2022to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be enrolled from Stanford University Hospital, which is a major urban center with a diverse patient population.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University Hospital
Palo Alto, California, 94304
Muhith Musabbir, 650-723-8886
About this study
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.
Read the detailed description
Post-stroke dementia is an important and understudied component of the vascular contributions to cognitive impairment and dementia. Having a stroke approximately doubles the risk of incident dementia for at least a decade afterwards, even after accounting for other vascular risk factors of dementia and the initial effects of the stroke lesion on cognition. Also, silent strokes occur in nearly half of all aging individuals and are associated with dementia. It has been established in wildtype mice that stroke triggers chronic neuroinflammation in the stroke scar and connected brain regions, and that this causes delayed-onset cognitive decline. In humans, there is neuroinflammation in the stroke scar in about half of all chronic stroke survivors on autopsy, even decades after stroke, suggesting it may play a role in people as well. However, there are no biomarkers that can currently be used in living humans to detect who is at risk of cognitive decline and dementia after stroke. The hypothesis to be tested is that inflammation-induced angiogenesis in the stroke and connected regions results in immature leaky vessels that cause blood-brain barrier leakage even very late after stroke. The goal is to establish that there is chronic blood-brain barrier dysfunction after stroke and a dysregulated angiogenesis as a potential mechanism. This would be a fundamental change in how post-stroke dementia is conceptualized and would open avenues for novel therapy development. This will also help better understand vascular contributions to cognitive impairment and dementia.
- Conditions
- Stroke
- Being tested
- DCE-MRI
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCE-MRIDiagnostic test
Both groups will undergo DCE-MRIs.
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Patients who have a history of stroke will be in the first group. Receives: 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. Receives: Diagnostic Test: DCE-MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start17 May 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, Columbia University
- Responsible party
- Principal investigator, Marion S Buckwalter, Stanford University
- Investigators
- Marion Buckwalter, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116630
- Sponsor's protocol ID
- 63979
- Status last verified
- Apr 2024
- First submitted
- 30 Oct 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StrokeCog-BBB to Study Cognitive Outcomes Following Stroke
- ClinicalTrials.gov ID
- NCT06116630
- Acronym / sponsor ID
- 63979
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of Manchester, Columbia University
- Study start
- 17 May 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Post-stroke dementia is an important and understudied component of the vascular contributions to cognitive impairment and dementia. Having a stroke approximately doubles the risk of incident dementia for at least a decade afterwards, even after accounting for other vascular risk factors of dementia and the initial effects of the stroke lesion on cognition. Also, silent strokes occur in nearly half of all aging individuals and are associated with dementia. It has been established in wildtype mice that stroke triggers chronic neuroinflammation in the stroke scar and connected brain regions, and that this causes delayed-onset cognitive decline. In humans, there is neuroinflammation in the stroke scar in about half of all chronic stroke survivors on autopsy, even decades after stroke, suggesting it may play a role in people as well. However, there are no biomarkers that can currently be used in living humans to detect who is at risk of cognitive decline and dementia after stroke. The hypothesis to be tested is that inflammation-induced angiogenesis in the stroke and connected regions results in immature leaky vessels that cause blood-brain barrier leakage even very late after stroke. The goal is to establish that there is chronic blood-brain barrier dysfunction after stroke and a dysregulated angiogenesis as a potential mechanism. This would be a fundamental change in how post-stroke dementia is conceptualized and would open avenues for novel therapy development. This will also help better understand vascular contributions to cognitive impairment and dementia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | Diagnostic Test: DCE-MRIPatients who have a history of stroke will be in the first group. |
| Control | – | Diagnostic Test: DCE-MRIPatients who do not have a history of stroke, but have a history of cardiovascular risk factors will be in the second group. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be enrolled from Stanford University Hospital, which is a major urban center with a diverse patient population.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCE-MRIBoth groups will undergo DCE-MRIs. | Diagnostic test | Control, Stroke |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marion Buckwalter, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhith Musabbir (650-723-8886, musabbir@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of leaky blood vessels in the brain and cognitive scores (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.