NCT04916210 Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY
| NCT ID | NCT04916210 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Ischemic Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 8,000 participants |
| Start Date | 2021-03-05 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 8,000 participants in total. It began in 2021-03-05 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Natalia Rost, MD, MPH
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT04916210 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04916210 currently recruiting?
Yes, NCT04916210 is actively recruiting participants. Contact the research team at meschia.james@mayo.edu for enrollment information.
Where is the NCT04916210 trial being conducted?
This trial is being conducted at Phoenix, United States, Los Angeles, United States, Los Angeles, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT04916210 clinical trial?
NCT04916210 is sponsored by Massachusetts General Hospital. The principal investigator is Natalia Rost, MD, MPH at Massachusetts General Hospital. The trial plans to enroll 8,000 participants.
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