Ischemic StrokeDISCOVERYNCT04916210
Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY
An observational study of Ischemic Stroke and Intracerebral Hemorrhage, run by Massachusetts General Hospital at 31 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage
- How many people
- 8,000 participants
- Where
- 31 sitesUnited States
- Study dates
- 5 Mar 2021to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with recent (≤ 6 weeks) acute ischemic stroke, intracerebral hemorrhage or aneurysmal subarachnoid hemorrhage and no history of dementia.
Who may be able to join
- 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
Who cannot join
- 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
- Additional exclusion criteria for Tier 2 participants:
- 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:
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- 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.
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
United States31 sites, 28 recruiting
- Active, not recruiting
University of Michigan
Ann Arbor, Michigan, 48109
- Recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
Gunjan Parikh, MD
Gunjan Parikh, MD
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Natalia Rost, MD
Natalia Rost, MD
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Hugo Aparicio, MD, MPH
Hugo Aparicio, MD, MPH
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Bradford Worrall, MD
Bradford Worrall, MD
- Recruiting
The University of Chicago Medical Center
Chicago, Illinois, 60637
Karen Orjuela, MD, MS
Karen Orjuela, MD, MS
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45219
Stacie Demel, DO, PhD
Stacie Demel, DO, PhD
- Recruiting
University of Colorado
Denver, Colorado, 80045
Jennifer Simpson, MD
Jennifer Simpson, MD
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27708
Nada El Husseini, MD, MHS
Nada El Husseini, MD, MHS
- Recruiting
Houston Methodist Research Institute
Houston, Texas, 77030
Rajan Gadhia, MD
Rajan Gadhia, MD
- Recruiting
UTHealth
Houston, Texas, 77030
Sean Savitz, MD
Seema Aggarwal, PhD, APRN, AGNP-C
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Jason Mackey, MD
Jason Mackey, MD
- Active, not recruiting
University of Iowa
Iowa City, Iowa, 52242
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Syed Hussain, MD, 601-984-5501, shussain1@umc.edu
Syed Hussain, MD
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Michelle Lin, MD, MPH
Michelle Lin, MD, MPH
- Recruiting
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Navdeep Sangha, MD
Pamela Cheng, DO
- Recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Shlee Song, MD
Shlee Song, MD
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
Jason Hinman, MD, 310-794-1195, Jhinman@mednet.ucla.edu
Jason Hinman, MD
- Recruiting
Methodist University Hospital
Memphis, Tennessee, 38104
Balaji Krishnaiah, MD
Balaji Krishnaiah, MD
- Recruiting
University of Miami Health System
Miami, Florida, 33125
Nicole Sur, MD
Nicole Sur, MD
- Recruiting
University of Minnesota Health
Minneapolis, Minnesota, 55455
Kamakshi Lakshminarayan, MD, PhD, MS
Kamakshi Lakshminarayan, MD, PhD, MS
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Michael Waters, MD, PhD
Michael Waters, MD, PhD
- Recruiting
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Kelly Sloane, MD
Kelly Sloane, MD
- Recruiting
Barrow Neurological Institute
Phoenix, Arizona, 85013
Joyce Lee-Iannotti, MD, 855-474-9152, joyce.lee-iannotti@commonspirit.org
Joyce Lee-Iannotti, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55902
Eugene Scharf, MD
Eugene Scharf, MD
- Recruiting
University of Utah
Salt Lake City, Utah, 84132
Jennifer Majersik, MD, MS
Jennifer Majersik, MD, MS
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Reza Behrouz, DO, 210-450-9700, behrouz@uthscsa.edu
Reza Behrouz, DO
- Recruiting
University of California San Diego
San Diego, California, 92037
Brett Meyer, MD
Brett Meyer, MD
- Recruiting
University of Washington, Harborview Medical Center
Seattle, Washington, 98104
Rizwan Kalani, MD
Rizwan Kalani, MD
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Daniel Labovitz, MD, 718-920-6444, dlabovit@montefiore.org
Daniel Labovitz, MD
- Active, not recruiting
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
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:
- 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.
- 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.
- 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.
- Conditions
- Ischemic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Dementia, Vascular, Mild Cognitive Impairment, Vascular Cognitive Impairment
- Medical subject headings
- Ischemic Stroke, Cerebral Hemorrhage, Subarachnoid Hemorrhage, Dementia, Vascular, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in post-stroke cognitive impairment and dementia (PSCID) diagnosis status
Measured: Baseline to 48 months post-index stroke
Secondary outcomes (1)
Change in cognitive function
Measured: Baseline to 3-6, 12, 18, 24, 36 and 48 months post-index stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start5 Mar 2021
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalia Rost, MD, Massachusetts General Hospital
- Investigators
- Natalia Rost, MD, MPH, Principal investigator, Massachusetts General HospitalSteven Greenberg, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916210
- Sponsor's protocol ID
- 2020P001099
- Other IDs
- U19NS115388
- Acronym
- DISCOVERY
- Status last verified
- Sep 2026
- First submitted
- 13 May 2021
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY
- ClinicalTrials.gov ID
- NCT04916210
- Acronym / sponsor ID
- DISCOVERY / 2020P001099
- Conditions
- Ischemic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Dementia, Vascular, Mild Cognitive Impairment, Vascular Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recent (≤ 6 weeks) acute ischemic stroke, intracerebral hemorrhage or aneurysmal subarachnoid hemorrhage and no history of dementia.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in post-stroke cognitive impairment and dementia (PSCID) diagnosis status
Time frame: Baseline to 48 months post-index stroke
1 secondary outcome
Change in cognitive function
Time frame: Baseline to 3-6, 12, 18, 24, 36 and 48 months post-index stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Official Website for the DISCOVERY StudyLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natalia Rost, MD, MPH principal investigator
Massachusetts General Hospital
Steven Greenberg, MD, PhD principal investigator
Massachusetts General Hospital
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Intracerebral Hemorrhage, run by Massachusetts General Hospital at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Meschia, MD (904-953-6515, meschia.james@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in post-stroke cognitive impairment and dementia (PSCID) diagnosis status (time frame: Baseline to 48 months post-index stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.