REpeated ASSEssment of SurvivorS in Intracerebral Hemorrhage Study

NCT ID: NCT05611918

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-23
• Study Completion Date: 2027-12-31

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy Ziai, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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

Mayo Clinic, Jacksonville

Jacksonville, Florida, 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 Kansas Medical Center

Fairway, Kansas, United States

University of Louisville

Louisville, Kentucky, United States

University of Maryland Baltimore

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, United States

Washington University in St. Louis, School of Medicine

St Louis, Missouri, United States

Rutgers - Robert Wood Johnson Medical School

Piscataway, New Jersey, United States

University of New Mexico

Albuquerque, New Mexico, United States

Albert Einstein Montefiore

The Bronx, New York, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas, Houston Health Science Center

Houston, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Inova Health System Foundation

Fairfax, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39915023 (View on PubMed)

Other Identifiers

R01NS120557

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00311985

Identifier Type: -

Identifier Source: org_study_id