ClinicalTrials.gg
RecruitingNCT04916210DISCOVERYUpdated Sep 14, 2026

Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY

An observational study in Ischemic Stroke, Intracerebral Hemorrhage and Subarachnoid Hemorrhage, sponsored by Massachusetts General Hospital. Recruiting at 31 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Massachusetts General Hospital · Observational

From the registry’s dates

  • Started Mar 2021; still recruiting 5 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
8,000
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Ischemic Stroke
  • Intracerebral Hemorrhage
  • Subarachnoid Hemorrhage
  • Dementia, Vascular
  • Mild Cognitive Impairment
  • Vascular Cognitive Impairment
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 8,000 is above the median of 300 across 771 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 by self or proxy
  6. Fluent in English or Spanish prior to stroke onset

Exclusion criteria

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. 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
8,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

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

    Time frame: Baseline to 48 months post-index stroke

Secondary outcomes

  1. Change in cognitive function

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

07

Study locations

28 of 31 sites recruiting
  • Barrow Neurological Institute
    Phoenix, Arizona 85013, United States
    Recruiting
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California 90027, United States
    Recruiting
    • Navdeep Sangha, MD · Contact
    • Pamela Cheng, DO · Contact
    • Navdeep Sangha, MD · Principal investigator
    • Pamela Cheng, DO · Principal investigator
  • Cedars Sinai Medical Center
    Los Angeles, California 90048, United States
    Recruiting
    • Shlee Song, MD · Contact
    • Shlee Song, MD · Principal investigator
  • University of California Los Angeles
    Los Angeles, California 90095, United States
    Recruiting
  • University of California San Diego
    San Diego, California 92037, United States
    Recruiting
    • Brett Meyer, MD · Contact
    • Brett Meyer, MD · Principal investigator
  • University of Colorado
    Denver, Colorado 80045, United States
    Recruiting
    • Jennifer Simpson, MD · Contact
    • Jennifer Simpson, MD · Principal investigator
  • Mayo Clinic
    Jacksonville, Florida 32224, United States
    Recruiting
    • Michelle Lin, MD, MPH · Contact
    • Michelle Lin, MD, MPH · Principal investigator
  • University of Miami Health System
    Miami, Florida 33125, United States
    Recruiting
    • Nicole Sur, MD · Contact
    • Nicole Sur, MD · Principal investigator
  • The University of Chicago Medical Center
    Chicago, Illinois 60637, United States
    Recruiting
    • Karen Orjuela, MD, MS · Contact
    • Karen Orjuela, MD, MS · Principal investigator
  • Indiana University
    Indianapolis, Indiana 46202, United States
    Recruiting
    • Jason Mackey, MD · Contact
    • Jason Mackey, MD · Principal investigator
  • University of Iowa
    Iowa City, Iowa 52242, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
    Recruiting
    • Gunjan Parikh, MD · Contact
    • Gunjan Parikh, MD · Principal investigator
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    Recruiting
    • Natalia Rost, MD · Contact
    • Natalia Rost, MD · Principal investigator
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
    Recruiting
    • Hugo Aparicio, MD, MPH · Contact
    • Hugo Aparicio, MD, MPH · Principal investigator
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • University of Minnesota Health
    Minneapolis, Minnesota 55455, United States
    Recruiting
    • Kamakshi Lakshminarayan, MD, PhD, MS · Contact
    • Kamakshi Lakshminarayan, MD, PhD, MS · Principal investigator
  • Mayo Clinic
    Rochester, Minnesota 55902, United States
    Recruiting
    • Eugene Scharf, MD · Contact
    • Eugene Scharf, MD · Principal investigator
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
    Recruiting
    • Syed Hussain, MD · Contactshussain1@umc.edu · 601-984-5501
    • Syed Hussain, MD · Principal investigator
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
    Recruiting
    • Michael Waters, MD, PhD · Contact
    • Michael Waters, MD, PhD · Principal investigator
  • Montefiore Medical Center
    The Bronx, New York 10467, United States
    Recruiting
    • Daniel Labovitz, MD · Contactdlabovit@montefiore.org · 718-920-6444
    • Daniel Labovitz, MD · Principal investigator
  • Duke University Medical Center
    Durham, North Carolina 27708, United States
    Recruiting
    • Nada El Husseini, MD, MHS · Contact
    • Nada El Husseini, MD, MHS · Principal investigator
  • Wake Forest Baptist Health
    Winston-Salem, North Carolina 27157, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • University of Cincinnati
    Cincinnati, Ohio 45219, United States
    Recruiting
    • Stacie Demel, DO, PhD · Contact
    • Stacie Demel, DO, PhD · Principal investigator
  • The Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
    • Kelly Sloane, MD · Contact
    • Kelly Sloane, MD · Principal investigator
  • Methodist University Hospital
    Memphis, Tennessee 38104, United States
    Recruiting
    • Balaji Krishnaiah, MD · Contact
    • Balaji Krishnaiah, MD · Principal investigator
  • Houston Methodist Research Institute
    Houston, Texas 77030, United States
    Recruiting
    • Rajan Gadhia, MD · Contact
    • Rajan Gadhia, MD · Principal investigator
  • UTHealth
    Houston, Texas 77030, United States
    Recruiting
    • Sean Savitz, MD · Contact
    • Seema Aggarwal, PhD, APRN, AGNP-C · Contact
    • Sean Savitz, MD · Principal investigator
    • Seema Aggarwal, PhD, APRN, AGNP-C · Principal investigator
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229, United States
    Recruiting
    • Reza Behrouz, DO · Contactbehrouz@uthscsa.edu · 210-450-9700
    • Reza Behrouz, DO · Principal investigator
  • University of Utah
    Salt Lake City, Utah 84132, United States
    Recruiting
    • Jennifer Majersik, MD, MS · Contact
    • Jennifer Majersik, MD, MS · Principal investigator
  • University of Virginia
    Charlottesville, Virginia 22903, United States
    Recruiting
    • Bradford Worrall, MD · Contact
    • Bradford Worrall, MD · Principal investigator
  • University of Washington, Harborview Medical Center
    Seattle, Washington 98104, United States
    Recruiting
    • Rizwan Kalani, MD · Contact
    • Rizwan Kalani, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided — Contingent upon approval from the DISCOVERY Project Steering Committee and Sharing Subcommittee, or the NINDS (upon completion of the study), data, imaging and/or samples from consenting participants may be shared with other external researchers for future research. All identifiers and study-specific codes will be removed and assigned a second randomized identifier. The key linking each identifier to a study-specific code will be in the possession of the DISCOVERY Repository Core and will not be shared with external researchers. Upon completion of the study, the study database will be available to NINDS along with a data dictionary and all information needed to utilize the data in future research in accordance with the informed consent. De-identified genetic information derived from this study will be deposited in the US NIH genomic database (dbGAP and future iterations) and used for future research.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04916210
Responsible party
Natalia Rost, MD (Professor of Neurology, Massachusetts General Hospital) — Principal investigator
First posted
Jun 7, 2021
Start date
Mar 5, 2021
Primary completion
Aug 31, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Sep 14, 2026

Study contacts

James Meschia, MD
Contact
meschia.james@mayo.edu
904-953-6515
Natalia Rost, MD, MPH
principal investigator · Massachusetts General Hospital
Steven Greenberg, MD, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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