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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05611918
Other study ID # IRB00311985
Secondary ID R01NS120557
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 23, 2023
Est. completion date December 31, 2027

Study information

Verified date May 2024
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


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
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