Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY

NCT ID: NCT04916210

Last Updated: 2025-11-03

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

8000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-05

Study Completion Date

2026-08-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Natalia Rost, MD

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

University of California Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

University of California San Diego

San Diego, California, United States

Site Status RECRUITING

University of Colorado

Denver, Colorado, United States

Site Status RECRUITING

Mayo Clinic

Jacksonville, Florida, United States

Site Status RECRUITING

University of Miami Health System

Miami, Florida, United States

Site Status RECRUITING

The University of Chicago Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

Indiana University

Indianapolis, Indiana, United States

Site Status RECRUITING

University of Iowa

Iowa City, Iowa, United States

Site Status ACTIVE_NOT_RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Boston Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

University of Michigan

Ann Arbor, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

University of Minnesota Health

Minneapolis, Minnesota, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Montefiore Medical Center

The Bronx, New York, United States

Site Status RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

University of Cincinnati

Cincinnati, Ohio, United States

Site Status RECRUITING

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Methodist University Hospital

Memphis, Tennessee, United States

Site Status RECRUITING

Houston Methodist Research Institute

Houston, Texas, United States

Site Status RECRUITING

UTHealth

Houston, Texas, United States

Site Status RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status RECRUITING

University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

University of Virginia

Charlottesville, Virginia, United States

Site Status RECRUITING

University of Washington, Harborview Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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James Meschia, MD

Role: CONTACT

904-953-6515

Facility Contacts

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Supreet Kaur, MD

Role: primary

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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https://discoverystudy.org/

Official Website for the DISCOVERY Study

Other Identifiers

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U19NS115388

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020P001099

Identifier Type: -

Identifier Source: org_study_id

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