Status:
RECRUITING
Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Ischemic Stroke
Intracerebral Hemorrhage
Eligibility:
All Genders
18+ years
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 ...
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 deme...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
8000 Patients enrolled
Trial Details
Trial ID
NCT04916210
Start Date
March 5 2021
End Date
August 31 2026
Last Update
November 3 2025
Active Locations (31)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
3
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
4
University of California Los Angeles
Los Angeles, California, United States, 90095