RecruitingNCT04916210

Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY


Sponsor

Massachusetts General Hospital

Enrollment

8,000 participants

Start Date

Mar 5, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • Age ≥18 years
  • 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)
  • 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)
  • 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

Exclusion Criteria7

  • 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
  • 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
  • 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.

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Locations(31)

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

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