Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY

NCT04916210 | Recruiting DMC

• 2 other identifiers: 2020P001099U19NS115388
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 31

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. 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. 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. 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.

Conditions

Ischemic Stroke; Intracerebral Hemorrhage; Subarachnoid Hemorrhage; Dementia, Vascular; Mild Cognitive Impairment; Vascular Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Change in post-stroke cognitive impairment and dementia (PSCID) diagnosis status

  Baseline to 48 months post-index stroke

Secondary Outcomes (1)

• Change in cognitive function

  Baseline to 3-6, 12, 18, 24, 36 and 48 months post-index stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with recent (≤ 6 weeks) acute ischemic stroke, intracerebral hemorrhage or aneurysmal subarachnoid hemorrhage and no history of dementia.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (31)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

RECRUITING

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

RECRUITING

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

University of California San Diego

San Diego, California, 92037, United States

RECRUITING

University of Colorado

Denver, Colorado, 80045, United States

RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

University of Miami Health System

Miami, Florida, 33125, United States

RECRUITING

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

ACTIVE NOT RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

ACTIVE NOT RECRUITING

University of Minnesota Health

Minneapolis, Minnesota, 55455, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55902, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27708, United States

RECRUITING

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

ACTIVE NOT RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45219, United States

RECRUITING

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Methodist University Hospital

Memphis, Tennessee, 38104, United States

RECRUITING

Houston Methodist Research Institute

Houston, Texas, 77030, United States

RECRUITING

UTHealth

Houston, Texas, 77030, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

University of Washington, Harborview Medical Center

Seattle, Washington, 98104, United States

RECRUITING

Related Links

• Official Website for the DISCOVERY Study

Biospecimen

Retention: SAMPLES WITH DNA

A blood sample will be collected from all participants at baseline for genomic and blood-based biomarker analyses. Tier 2 and 3 participants will undergo additional blood draws at each in-person follow-up visit for the collection of whole blood and RNA for longitudinal blood-based biomarker and DNA methylation (DNAm) analyses. Plasma, whole blood and RNA samples will be frozen and stored at the DISCOVERY Biorepository at the University of California, San Diego (UCSD) or the University of Southern California (USC) for further processing, storage and analysis.

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Hemorrhage; Subarachnoid Hemorrhage; Dementia, Vascular; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Natalia Rost, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Steven Greenberg, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Meschia, MD

CONTACT

904-953-6515; meschia.james@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: June 7, 2021
• Study Start: March 5, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Locations

US (31)