Recruiting

Observational StudyDeterminants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY

Sponsor:

Massachusetts General Hospital

Code:

NCT04916210

Conditions

Ischemic Stroke

Intracerebral Hemorrhage

Subarachnoid Hemorrhage

Dementia, Vascular

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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. 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.

Conditions

Ischemic Stroke

Intracerebral Hemorrhage

Subarachnoid Hemorrhage

Dementia, Vascular

Mild Cognitive Impairment

Study ID

NCT04916210

Start date

Mar 5, 2021

Status verified date

Oct, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

8000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Change in post-stroke cognitive impairment and dementia (PSCID) diagnosis status [ Time Frame: Baseline to 48 months post-index stroke ]

Central Contacts and Locations

Central contacts

James Meschia, MD

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

Locations

Barrow Neurological Institute

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Supreet Kaur, MD

supreet.kaur@dignityhealth.org

Principal Investigator:

Supreet Kaur, MD

Kaiser Permanente Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90027

Principal Investigator:

Navdeep Sangha, MD

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Principal Investigator:

Shlee Song, MD

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Principal Investigator:

Katherine Mun, MD

University of California San Diego

Recruiting

San Diego, California, United States, 92037

Principal Investigator:

Brett Meyer, MD

University of Colorado

Recruiting

Denver, Colorado, United States, 80045

Principal Investigator:

Jennifer Simpson, MD

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Principal Investigator:

Michelle Lin, MD, MPH

University of Miami Health System

Recruiting

Miami, Florida, United States, 33125

Principal Investigator:

Nicole Sur, MD

The University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Principal Investigator:

Karen Orjuela, MD, MS

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Jason Mackey, MD

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Principal Investigator:

Gunjan Parikh, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Natalia Rost, MD

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Principal Investigator:

Hugo Aparicio, MD, MPH

University of Minnesota Health

Recruiting

Minneapolis, Minnesota, United States, 55455

Principal Investigator:

Kamakshi Lakshminarayan, MD, PhD, MS

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

Principal Investigator:

Eugene Scharf, MD

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Principal Investigator:

Shreyas Gangadhara, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Michael Waters, MD, PhD

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Principal Investigator:

Daniel Antoniello, MD

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27708

Principal Investigator:

Nada El Husseini, MD, MHS

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

Principal Investigator:

Stacie Demel, DO, PhD

The Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Kelly Sloane, MD

Methodist University Hospital

Recruiting

Memphis, Tennessee, United States, 38104

Principal Investigator:

Balaji Krishnaiah, MD

Houston Methodist Research Institute

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Rajan Gadhia, MD

UTHealth

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Sean Savitz, MD

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

Andrew Slusher, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Principal Investigator:

Jennifer Majersik, MD, MS

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Principal Investigator:

Bradford Worrall, MD

University of Washington, Harborview Medical Center

Recruiting

Seattle, Washington, United States, 98104

Principal Investigator:

Rizwan Kalani, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 3, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-03.