REpeated ASSEssment of SurvivorS in Intracerebral Hemorrhage Study (ICH03)

Johns Hopkins University

Status: Invitation-only

Conditions: Hemorrhage; Cognitive Impairment; Stroke; Survivorship; Clot (Blood); Brain; Cognitive Decline; Memory Impairment; ICH - Intracerebral Hemorrhage; Clot Blood; ICH; Intra Cerebral Hemorrhage; Motor Activity

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05611918

IRB00311985

R01NS120557 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants in the study must be survivors enrolled in MISTIE III and ENRICH trials at end of each trial's final follow-up (day 365 in MISTIE III and day 180 in ENRICH). Relatives of known survivors that are found to be deceased since the end of each trial will be interviewed to capture relevant data.

Exclusion criteria

• None