Understanding cognitive changes after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify factors that influence cognitive outcomes in patients who have experienced an acute ischemic stroke, intracerebral hemorrhage, or aneurysmal subarachnoid hemorrhage. It will enroll 8,000 patients who will undergo baseline cognitive assessments, blood draws, and follow-up evaluations over time to monitor changes in cognitive function. The study will also utilize advanced imaging techniques to explore biomarkers associated with dementia. The goal is to help develop future treatments to improve cognitive recovery in stroke patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years
2. Admitted to the enrolling clinical performance site (CPS) hospital with a diagnosis of acute ischemic stroke (AIS), intracerebral hemorrhage (ICH), or aneurysmal subarachnoid hemorrhage (aSAH)
3. Radiographic confirmatory evidence of: (1) AIS (based on a focal area of restricted diffusion on MRI), (2) non-traumatic primary ICH (based on evidence of acute parenchymal hemorrhage on CT or brain MRI) or (3) non-traumatic acute aSAH (based on evidence of subarachnoid hemorrhage on CT or MRI and evidence of aneurysm on CT angiography, MR angiography, or conventional catheter-based angiography)
4. Able to complete baseline visit in person or by phone within 6 weeks of stroke onset
5. Able to provide informed consent by self or proxy
6. Fluent in English or Spanish prior to stroke onset

Exclusion Criteria:

1. Documented history of pre-stroke dementia or fails dementia pre-screen
2. Concurrently enrolled into a study that is not approved under the DISCOVERY Co-Enrollment Policy
3. Unable to complete study protocol (advanced directives such as comfort measures only, or inability to complete the study due to severe medical/behavioral co-morbidities), as determined by physician investigator during screening process

   Additional exclusion criteria for Tier 2 participants:
4. Contraindication to MRI: presence of electrically, magnetically, or mechanically activated implants (such as cardiac pacemakers, cochlear implants, implanted pumps); or metallic clips in the brain

   Additional exclusion criteria for Tier 3 participants:
5. Age \<50 years
6. Biologically female individuals who are pregnant or seeking to become pregnant
7. Known to have one of the following genetic conditions which can increase the risk of developing cancer: Cowden disease, Lynch syndrome, hypogammaglobulinemia, Wiskott-Aldrich syndrome, Down's syndrome.

Where it's running

• Barrow Neurological Institute
  Phoenix, Arizona, United States Recruiting
• Kaiser Permanente Los Angeles Medical Center
  Los Angeles, California, United States Recruiting
• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of California Los Angeles
  Los Angeles, California, United States Recruiting
• University of California San Diego
  San Diego, California, United States Recruiting
• University of Colorado
  Denver, Colorado, United States Recruiting

Study contacts

• Principal investigator: Natalia Rost, MD, MPH — Massachusetts General Hospital
• Study coordinator: James Meschia, MD
• Email: meschia.james@mayo.edu
• Phone: 904-953-6515

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.