Clinical trial NCT05611918: REpeated ASSEssment of SurvivorS in Intracerebral Hemorrhage Study
Official title: The Repeated Assessment of Survivors in ICH (REASSESS ICH)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Intra Cerebral Hemorrhage
ICH - Intracerebral Hemorrhage
ICH
Hemorrhage
Stroke
Clot (Blood); Brain
Clot Blood
Cognitive Decline
Cognitive Impairment
Survivorship
Memory Impairment
Motor Activity
Keywords: Intracerebral hemorrhage
Stroke
Cognitive Impairment
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: National Institute on Aging (NIA)
First posted: 2022-11-10
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study populations includes all surviving cases identified and recruited through the 5-year durations of the MISTIE III and ENRICH trials and with follow-up periods extending from 2013-2017 and 2016-2022, respectively.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine if surgical clot reduction after ICH reduces the risk of progressive cognitive decline.
timeFrame: 24 months
Secondary outcomes:
measure: To determine if there is a long-term benefit in survival and functional outcome from minimally invasive surgery whether or not cognitive decline occurs
timeFrame: 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Brimingham
state: Alabama
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Sacramento
country: United States
facility: Dignity Health component - St. Joseph's Hospital and Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic, Jacksonville
state: Florida
city: Chicago
country: United States
facility: CommonSpirit (formerly Mercy San Juan Medical Center; dignity health)
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Fairway
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin Healthcare Research Institute
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University in St. Louis, School of Medicine
state: Missouri
city: Piscataway
country: United States
facility: Rutgers - Robert Wood Johnson Medical School
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Bronx
country: United States
facility: Albert Einstein Montefiore
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas, Houston Health Science Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Fairfax
country: United States
facility: Inova Health System Foundation
state: Virginia
Study officials:
affiliation: Johns Hopkins University
name: Wendy Ziai, MD
role: PRINCIPAL_INVESTIGATOR
References: