Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY
- Conditions
- Ischemic StrokeDementia, VascularVascular Cognitive ImpairmentIntracerebral HemorrhageSubarachnoid HemorrhageMild Cognitive Impairment
- Registration Number
- NCT04916210
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
The overall goal of the DISCOVERY study is to better understand what factors contribute to changes in cognitive (i.e., thinking and memory) abilities in patients who experienced a stroke. The purpose of the study is to help doctors identify patients at risk for dementia (decline in memory, thinking and other mental abilities that significantly affects daily functioning) after their stroke so that future treatments may be developed to improve outcomes in stroke patients. For this study, a "stroke" is defined as either (1) an acute ischemic stroke (AIS, or blood clot in the brain), (2) an intracerebral hemorrhage (ICH, or bleeding in the brain), (3) or an aneurysmal subarachnoid hemorrhage (aSAH, or bleeding around the brain caused by an abnormal bulge in a blood vessel that bursts).
The investigators hypothesize that:
1. The size, type and location of the stroke play an important role in recovery of thinking and memory abilities after stroke, and pre-existing indicators of brain health further determine the extent of this recovery.
2. Specific stroke events occurring in individuals with underlying genetic or biological risk factors can cause further declines in brain heath, leading to changes in thinking and memory abilities after stroke.
3. Studying thinking and memory alongside brain imaging and blood samples in patients who have had a stroke allows for earlier identification of declining brain health and development of individualized treatment plans to improve patient outcomes in the future.
- Detailed Description
This is a prospective, multi-center, observational, nested-cohort study. A total of 8,000 patients hospitalized at the DISCOVERY clinical sites with acute-onset AIS, ICH or aSAH and no history of dementia will be enrolled.
All participants will undergo baseline screening for evidence of pre-stroke dementia. Those who pass baseline screening will complete a blood draw and a series of cognitive and functional assessments at baseline.
Participants will undergo in-person (3-6 months, 18 months) and telephone (annual) follow-up visits for the duration of the study to assess for longitudinal cognitive and functional outcomes. In addition to Tier 1 procedures, at each in-person follow-up visit, Tier 2 participants will also undergo brain MRI scanning, comprehensive cognitive assessment batteries and longitudinal blood collection; and Tier 3 participants will also complete a specialized imaging of the brain (amyloid- and tau-PET/CT scans), which is intended to identify special biomarkers of dementia.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 8000
- Age ≥18 years
- Admitted to the hospital with a diagnosis of acute ischemic stroke (AIS), intracerebral hemorrhage (ICH), or aneurysmal subarachnoid hemorrhage (aSAH)
- Radiographic confirmatory evidence of: (1) AIS (based on a focal area of restricted diffusion on MRI), (2) non-traumatic ICH (based on evidence of acute parenchymal hemorrhage 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)
- Able to complete baseline visit in person or by phone within 6 weeks of stroke onset
- Able to provide informed consent by self or proxy
- Fluent in English or Spanish prior to stroke onset
-
Documented history of pre-stroke dementia or fails dementia pre-screen
-
Concurrently enrolled into a study that is not approved under the DISCOVERY Co-Enrollment Policy
-
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:
-
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:
-
Age <50 years
-
Biologically female individuals who are pregnant or seeking to become pregnant
-
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in post-stroke cognitive impairment and dementia (PSCID) diagnosis status Baseline to 48 months post-index stroke
- Secondary Outcome Measures
Name Time Method Change in cognitive function Baseline to 3-6, 12, 18, 24, 36 and 48 months post-index stroke
Trial Locations
- Locations (29)
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
University of California San Diego
🇺🇸San Diego, California, United States
University of Miami Health System
🇺🇸Miami, Florida, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
University of Minnesota Health
🇺🇸Minneapolis, Minnesota, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
The Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
Houston Methodist Research Institute
🇺🇸Houston, Texas, United States
UTHealth
🇺🇸Houston, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
University of Washington, Harborview Medical Center
🇺🇸Seattle, Washington, United States
University of Colorado
🇺🇸Denver, Colorado, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States