REpeated ASSEssment of SurvivorS in Intracerebral Hemorrhage Study

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.

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Key information

Conditions

Intra Cerebral Hemorrhage Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Clot (Blood); Brain Clot Blood Cognition Disorders Cognitive Decline Cognitive Dysfunction Cognitive Impairment Embolism and Thrombosis Hemorrhage ICH ICH - Intracerebral Hemorrhage Intracranial Embolism and Thrombosis Intracranial Hemorrhages Intracranial Thrombosis Memory Disorders Memory Impairment Mental Disorders Motor Activity Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Survivorship Thromboembolism Thrombosis Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Brimingham, Birmingham, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

To determine if surgical clot reduction after ICH reduces the risk of progressive cognitive decline.

Time frame: 24 months

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.

Secondary outcomes

To determine if there is a long-term benefit in survival and functional outcome from minimally invasive surgery whether or not cognitive decline occurs

Time frame: 24 months

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).

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)

Registry information

Official study title

The Repeated Assessment of Survivors in ICH (REASSESS ICH)

Acronym: ICH03

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2027
First posted: Nov 10, 2022
Registry last updated: Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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