Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY (DISCOVERY)

J
Jason Mackey

Primary Investigator

Enrolling By Invitation
18 years and older
All
Phase N/A
8000 participants needed
1 Location

Brief description of study

The overall goal of the DISCOVERY study is to better understand what factors contribute tohanges in cognitive (i.e., thinking and memory) abilities in patients who experienced ake. 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 dailyunctioning) after their stroke so that future treatments may be developed to improveutcomes in stroke patients. For this study, a "stroke" is defined as either (1) an acutehemic 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 bleedingund 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 thinkingd 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 biologicalk factors can cause further declines in brain heath, leading to changes in thinkingd 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 of study

This is a prospective, multi-center, observational, nested-cohort study. A total of 8,000hospitalized at the DISCOVERY clinical sites with acute-onset AIS, ICH or aSAH andhistory 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 andunctional 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 functionalutcomes. In addition to Tier 1 procedures, at each in-person follow-up visit, Tier 2will also undergo brain MRI scanning, comprehensive cognitive assessment batteries and longitudinal blood collection; and Tier 3 participants will also complete azed imaging of the brain (amyloid- and tau-PET/CT scans), which is intended todentify special biomarkers of dementia.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ischemic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Dementia, Vascular, Mild Cognitive Impairment, Vascular Cognitive Impairment
  • Age: 18 Years
  • Gender: All

Inclusion Criteria:
  1. Age ≥18 years
  2. Admitted to the hospital with a diagnosis of acute ischemic stroke (AIS),bral hemorrhage (ICH), or aneurysmal subarachnoid hemorrhage (aSAH)
  3. Radiographic confirmatory evidence of: (1) AIS (based on a focal area of restricteddiffusion on MRI), (2) non-traumatic ICH (based on evidence of acute parenchymalhemorrhage CT or brain MRI) or (3) non-traumatic acute aSAH (based on evidence ofubarachnoid hemorrhage on CT or MRI and evidence of aneurysm on CT angiography, MRgiography, 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 DISCOVERYCo-Enrollment Policy
  3. Unable to complete study protocol (advanced directives such as comfort measures only,bility to complete the study due to severe medical/behavioral co-morbidities),determined by physician investigator during screening process
    Additional exclusion criteria for Tier 2 participants:
  4. Contraindication to MRI: presence of electrically, magnetically, or mechanicallyvated implants (such as cardiac pacemakers, cochlear implants, implanted pumps);he brain
    Additional exclusion criteria for Tier 3 participants:
  5. Age <50 years
  6. Women who are pregnant or seeking to become pregnant
  7. Known to have one of the following genetic conditions which can increase the risk ofdeveloping cancer: Cowden disease, Lynch syndrome, hypogammaglobulinemia,Wiskott-Aldrich syndrome, Down's syndrome.

Updated on 01 Aug 2024. Study ID: 2020P001099
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