Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY
NCT ID: NCT04916210
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
8000 participants
OBSERVATIONAL
2021-03-05
2026-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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
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
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.
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Natalia Rost, MD
Professor of Neurology
Principal Investigators
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Natalia Rost, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Steven Greenberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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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 Colorado
Denver, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
University of Miami Health System
Miami, Florida, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, 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
Mayo Clinic
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, 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
Countries
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Central Contacts
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Facility Contacts
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Navdeep Sangha, MD
Role: primary
Pamela Cheng, DO
Role: backup
Shlee Song, MD
Role: primary
Katherine Mun, MD
Role: primary
Brett Meyer, MD
Role: primary
Jennifer Simpson, MD
Role: primary
Michelle Lin, MD, MPH
Role: primary
Nicole Sur, MD
Role: primary
Karen Orjuela, MD, MS
Role: primary
Jason Mackey, MD
Role: primary
Gunjan Parikh, MD
Role: primary
Natalia Rost, MD
Role: primary
Hugo Aparicio, MD, MPH
Role: primary
Kamakshi Lakshminarayan, MD, PhD, MS
Role: primary
Eugene Scharf, MD
Role: primary
Shreyas Gangadhara, MD
Role: primary
Michael Waters, MD, PhD
Role: primary
Daniel Antoniello, MD
Role: primary
Nada El Husseini, MD, MHS
Role: primary
Stacie Demel, DO, PhD
Role: primary
Kelly Sloane, MD
Role: primary
Balaji Krishnaiah, MD
Role: primary
Rajan Gadhia, MD
Role: primary
Sean Savitz, MD
Role: primary
Seema Aggarwal, PhD, APRN, AGNP-C
Role: backup
Andrew Slusher, MD
Role: primary
Jennifer Majersik, MD, MS
Role: primary
Bradford Worrall, MD
Role: primary
Rizwan Kalani, MD
Role: primary
Related Links
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Official Website for the DISCOVERY Study
Other Identifiers
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2020P001099
Identifier Type: -
Identifier Source: org_study_id
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