REpeated ASSEssment of SurvivorS in Intracerebral Hemorrhage Study

N/AEnrolling By InvitationNCT05611918

Johns Hopkins University350 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

350

Conditions

Intra Cerebral Hemorrhage ICH - Intracerebral Hemorrhage ICH Hemorrhage

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (26)

University of Alabama at Brimingham

Birmingham, Alabama, United States

Scripps Health

La Jolla, California, United States

Dignity Health component - St. Joseph's Hospital and Medical Center

Sacramento, California, United States

Stanford University

Stanford, California, United States

Yale University

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

To determine if surgical clot reduction after ICH reduces the risk of progressive cognitive decline.

Primary outcome measure is the rate of cognitive decline which is based on a composite measure of global cognition using the National Institute on Aging Genetics Initiative for Late Onset Alzheimer Disease (NIA-LOAD) Battery. Clot reduction measure will be obtained from semi-automated computerized volumetrics using the OsiriX software. National Institute on Aging Genetics Initiative for Late Onset Alzheimer Disease (NIA-LOAD) Battery is a 7-measure cognitive testing battery to assess change in episodic, semantic, and working memory in community-dwelling older persons with broad ability levels.

Time frame: 24 months

Secondary Outcomes

To determine if there is a long-term benefit in survival and functional outcome from minimally invasive surgery whether or not cognitive decline occurs

Survival and poor functional outcome (Modified Rankin Score (mRS) 4-6) will be calculated separately for cases with \<=20 mL and \>20 mL volume. We will use statistical modeling similar to Aim 1 to compute and calculate differences in hazard ratios for risk of mortality and poor outcome among \<=20 mL and \>20 mL survivors. We will assess interaction between cognitive decline and functional performance decline to evaluate whether these decline together. Secondary outcome measures include the following: Modified Rankin Scale score (mRS), NIH Stroke Scale (NIHSS), Motor Assessment Scale (MAS), Western Aphasia Battery (WAB), Mini Mental Status Exam (MMSE), Barthel Index (BI), De Jong Gierveld Loneliness Scale, EuroQol 5 Dimension (EQ-5D), Activities of Daily Living (ADL) and fall history, Telephone Interview for Cognitive Status (TICS), Informant Questionnaire on Cognitive Decline in the Elderly (IQ-CODE) and Center for Epidemiological Studies Depression (CES-D).

Time frame: 24 months