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NCT04916210Recruiting

Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY

Massachusetts General Hospital

Start Date

3/5/2021

Completion Date

8/31/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

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Conditions

Ischemic StrokeIntracerebral HemorrhageSubarachnoid HemorrhageDementia, VascularMild Cognitive ImpairmentVascular Cognitive Impairment

Locations

Barrow Neurological Institute

Phoenix, Arizona 85013

United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California 90027

United States

Cedars Sinai Medical Center

Los Angeles, California 90048

United States

University of California Los Angeles

Los Angeles, California 90095

United States

University of California San Diego

San Diego, California 92037

United States

University of Colorado

Denver, Colorado 80045

United States

Mayo Clinic

Jacksonville, Florida 32224

United States

University of Miami Health System

Miami, Florida 33125

United States

The University of Chicago Medical Center

Chicago, Illinois 60637

United States

Indiana University

Indianapolis, Indiana 46202

United States

University of Iowa

Iowa City, Iowa 52242

United States

University of Maryland Medical Center

Baltimore, Maryland 21201

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

University of Minnesota Health

Minneapolis, Minnesota 55455

United States

Mayo Clinic

Rochester, Minnesota 55902

United States

University of Mississippi Medical Center

Jackson, Mississippi 39216

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Montefiore Medical Center

The Bronx, New York 10467

United States

Duke University Medical Center

Durham, North Carolina 27708

United States

Wake Forest Baptist Health

Winston-Salem, North Carolina 27157

United States

University of Cincinnati

Cincinnati, Ohio 45219

United States

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Methodist University Hospital

Memphis, Tennessee 38104

United States

Houston Methodist Research Institute

Houston, Texas 77030

United States

UTHealth

Houston, Texas 77030

United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas 78229

United States

University of Utah

Salt Lake City, Utah 84132

United States

University of Virginia

Charlottesville, Virginia 22903

United States

University of Washington, Harborview Medical Center

Seattle, Washington 98104

United States