Understanding cognitive changes after stroke
Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY
This study is trying to find out what affects thinking and memory changes in people who have had a stroke, to help improve recovery in the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 8000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 31 sites (Phoenix, Arizona and 30 other locations) |
| Trial ID | NCT04916210 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been hospitalized for an acute stroke without a prior history of dementia.
Not a fit: Patients with a documented history of pre-stroke dementia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better identification of stroke patients at risk for dementia and improved treatment strategies.
How similar studies have performed: Other studies have shown promise in understanding cognitive outcomes post-stroke, but this specific approach is novel in its comprehensive assessment of biomarkers and cognitive function.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Phoenix, Arizona and 30 other locations
- 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)
- Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
- University of Miami Health System — Miami, Florida, United States (Recruiting)
- The University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Active_not_recruiting)
- University of Maryland Medical Center — Baltimore, Maryland, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Active_not_recruiting)
- University of Minnesota Health — Minneapolis, Minnesota, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- University of Mississippi Medical Center — Jackson, Mississippi, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- Wake Forest Baptist Health — Winston-Salem, North Carolina, United States (Active_not_recruiting)
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
- The Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Methodist University Hospital — Memphis, Tennessee, United States (Recruiting)
- Houston Methodist Research Institute — Houston, Texas, United States (Recruiting)
- UTHealth — Houston, Texas, United States (Recruiting)
- University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
- University of Washington, Harborview Medical Center — Seattle, Washington, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.