Trials / Enrolling By Invitation
Enrolling By InvitationNCT05611918
REpeated ASSEssment of SurvivorS in Intracerebral Hemorrhage Study
The Repeated Assessment of Survivors in ICH (REASSESS ICH)
- Status
- Enrolling By Invitation
- Phase
- —
- Study type
- Observational
- Enrollment
- 350 (estimated)
- Sponsor
- Johns Hopkins University · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The investigators propose to perform serial detailed cognitive, motor, behavioral, and blood collection follow-up using longitudinal structured telephone interviews of an anticipated 350 ICH survivors enrolled in Minimally Invasive Surgery Plus Alteplase for Intracerebral Hemorrhage Evacuation (MISTIE) III and ENRICH trials to identify specific cognitive and motor impairment and to perform RNA sequencing to evaluate for evidence of chronic inflammation. The investigators' expected sample size in 2022 accounts for mortality attrition of 10%/year.
Detailed description
The REASSESS study will conduct long-term cognitive, functional, and neuropsychiatric performance assessments to determine if evacuation of spontaneous intracerebral hemorrhage (ICH) reduces the risk of later cognitive decline in the ageing brain. This study will compare rates of cognitive decline under two treatment strategies for intracerebral hemorrhage: the use of minimally invasive surgery with two similar techniques as performed in the MISTIE III and ENRICH trials, and the current standard of care using data from controls in MISTIE III and ENRICH and comparative data from The Ethnic/Racial Variations of ICH (ERICH) study (U-01-NS067963) extended into the ERICH-Longitudinal study (R01-NS093870) which followed over 900 of ERICH cases with serial cognitive examinations.
Conditions
- Intra Cerebral Hemorrhage
- ICH - Intracerebral Hemorrhage
- ICH
- Hemorrhage
- Stroke
- Clot (Blood); Brain
- Clot Blood
- Cognitive Decline
- Cognitive Impairment
- Survivorship
- Memory Impairment
- Motor Activity
Timeline
- Start date
- 2023-05-23
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
- First posted
- 2022-11-10
- Last updated
- 2025-06-15
Locations
26 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05611918. Inclusion in this directory is not an endorsement.