Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U19NS115388 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in post-stroke cognitive impairment and dementia (PSCID) diagnosis status | Baseline to 48 months post-index stroke |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cognitive function | Baseline to 3-6, 12, 18, 24, 36 and 48 months post-index stroke |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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:
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.
Not provided
Not provided
Not provided
Patients with recent (≤ 6 weeks) acute ischemic stroke, intracerebral hemorrhage or aneurysmal subarachnoid hemorrhage and no history of dementia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Meschia, MD | Contact | 904-953-6515 | meschia.james@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Natalia Rost, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Steven Greenberg, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Recruiting | Phoenix | Arizona | 85013 | United States |
Not provided
| Label | URL |
|---|---|
| Official Website for the DISCOVERY Study | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| Kaiser Permanente Los Angeles Medical Center | Recruiting | Los Angeles | California | 90027 | United States |
|
| Cedars Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
|
| University of California Los Angeles | Recruiting | Los Angeles | California | 90095 | United States |
|
| University of California San Diego | Recruiting | San Diego | California | 92037 | United States |
|
| University of Colorado | Recruiting | Denver | Colorado | 80045 | United States |
|
| Mayo Clinic | Recruiting | Jacksonville | Florida | 32224 | United States |
|
| University of Miami Health System | Recruiting | Miami | Florida | 33125 | United States |
|
| The University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
|
| Indiana University | Recruiting | Indianapolis | Indiana | 46202 | United States |
|
| University of Iowa | Active, not recruiting | Iowa City | Iowa | 52242 | United States |
| University of Maryland Medical Center | Recruiting | Baltimore | Maryland | 21201 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
|
| Boston Medical Center | Recruiting | Boston | Massachusetts | 02118 | United States |
|
| University of Michigan | Active, not recruiting | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota Health | Recruiting | Minneapolis | Minnesota | 55455 | United States |
|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55902 | United States |
|
| University of Mississippi Medical Center | Recruiting | Jackson | Mississippi | 39216 | United States |
|
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
|
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10467 | United States |
|
| Duke University Medical Center | Recruiting | Durham | North Carolina | 27708 | United States |
|
| Wake Forest Baptist Health | Active, not recruiting | Winston-Salem | North Carolina | 27157 | United States |
| University of Cincinnati | Recruiting | Cincinnati | Ohio | 45219 | United States |
|
| The Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Methodist University Hospital | Recruiting | Memphis | Tennessee | 38104 | United States |
|
| Houston Methodist Research Institute | Recruiting | Houston | Texas | 77030 | United States |
|
| UTHealth | Recruiting | Houston | Texas | 77030 | United States |
|
| University of Texas Health Science Center at San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
|
| University of Utah | Recruiting | Salt Lake City | Utah | 84132 | United States |
|
| University of Virginia | Recruiting | Charlottesville | Virginia | 22903 | United States |
|
| University of Washington, Harborview Medical Center | Recruiting | Seattle | Washington | 98104 | United States |
|
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002543 | Cerebral Hemorrhage |
| D013345 | Subarachnoid Hemorrhage |
| D015140 | Dementia, Vascular |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D003704 | Dementia |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
Not provided
Not provided