REpeated ASSEssment of SurvivorS in Intracerebral Hemorrhage Study
ICH03
The Repeated Assessment of Survivors in ICH (REASSESS ICH)
2 other identifiers
observational
350
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2022
CompletedFirst Posted
Study publicly available on registry
November 10, 2022
CompletedStudy Start
First participant enrolled
May 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
June 15, 2025
June 1, 2025
3.6 years
November 3, 2022
June 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To determine if there is a long-term benefit in survival and functional outcome from minimally invasive surgery whether or not cognitive decline occurs
24 months
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
University of Alabama at Brimingham
Birmingham, Alabama, 35294, United States
Scripps Health
La Jolla, California, 92037, United States
Dignity Health component - St. Joseph's Hospital and Medical Center
Sacramento, California, 95819, United States
Stanford University
Stanford, California, 94305, United States
Yale University
New Haven, Connecticut, 06511, United States
Mayo Clinic, Jacksonville
Jacksonville, Florida, 32224, United States
CommonSpirit (formerly Mercy San Juan Medical Center; dignity health)
Chicago, Illinois, 60606, United States
University of Illinois at Chicago
Chicago, Illinois, 60607, United States
University of Kansas Medical Center
Fairway, Kansas, 66205, United States
University of Louisville
Louisville, Kentucky, 40292, United States
University of Maryland Baltimore
Baltimore, Maryland, 21201, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21205, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55415, United States
Washington University in St. Louis, School of Medicine
St Louis, Missouri, 63130, United States
Rutgers - Robert Wood Johnson Medical School
Piscataway, New Jersey, 08854, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Albert Einstein Montefiore
The Bronx, New York, 10461, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati
Cincinnati, Ohio, 45220, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Texas, Houston Health Science Center
Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Inova Health System Foundation
Fairfax, Virginia, 22042, United States
Related Publications (1)
Ziai W, Woo D, Sansing L, Hanley D, Ostapkovich N, Triene K, Gilkerson LA, Thompson R, Walborn N, Lane K, McBee N, Langefeld CD, Howard TD, Vagal A, Flaherty ML. The REpeated ASSEssment of SurvivorS in intracerebral haemorrhage: protocol for a multicentre, prospective observational study. BMJ Open. 2025 Feb 6;15(2):e094322. doi: 10.1136/bmjopen-2024-094322.
PMID: 39915023DERIVED
Biospecimen
Complete Blood Count, Ribonucleic Acid, Deoxyribonucleic Acid
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wendy Ziai, MD
Johns Hopkins University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2022
First Posted
November 10, 2022
Study Start
May 23, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
June 15, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- 9 months of database lock
- Access Criteria
- We will share individual-participant-level data, in a de-identified format in compliance with the HIPAA privacy rule, which will make the data free of identifiers that would permit linkages to the research participants and free of content that would create unacceptable risk of subject identification.
NIH policy states grant award recipients must make unique resources readily available for research purposes to qualified individuals within the scientific community after publication. Drs. Ziai and Flaherty are committed to sharing resources, products, and data generated in this study. They are aware of and agree to abide by the principles for sharing research resources as described by NIH in "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Programs."