REpeated ASSEssment of SurvivorS in Intracerebral Hemorrhage Study

Stroke Clinical Trial

— ICH03  

Official title:

The Repeated Assessment of Survivors in ICH (REASSESS ICH)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05611918
• Other study ID #: IRB00311985
• Secondary ID: R01NS120557
• Status: Enrolling by invitation
• Start date: May 23, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 350
• Est. completion date: December 31, 2027
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	University of Michigan	Ann Arbor	Michigan
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Maryland Baltimore	Baltimore	Maryland
United States	University of Alabama at Brimingham	Birmingham	Alabama
United States	Albert Einstein Montefiore	Bronx	New York
United States	CommonSpirit (formerly Mercy San Juan Medical Center; dignity health)	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Inova Health System Foundation	Fairfax	Virginia
United States	University of Kansas Medical Center	Fairway	Kansas
United States	University of Texas, Houston Health Science Center	Houston	Texas
United States	Mayo Clinic, Jacksonville	Jacksonville	Florida
United States	Scripps Health	La Jolla	California
United States	University of Louisville	Louisville	Kentucky
United States	Hennepin Healthcare Research Institute	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Rutgers - Robert Wood Johnson Medical School	Piscataway	New Jersey
United States	Dignity Health component - St. Joseph's Hospital and Medical Center	Sacramento	California
United States	Washington University in St. Louis, School of Medicine	Saint Louis	Missouri
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Stanford University	Stanford	California
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Secondary	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).	24 months