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REpeated ASSEssment of SurvivorS in Intracerebral Hemorrhage Study (ICH03)

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ClinicalTrials.gov Identifier: NCT05611918
Recruitment Status : Enrolling by invitation
First Posted : November 10, 2022
Last Update Posted : May 24, 2023
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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.

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

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Repeated Assessment of Survivors in ICH (REASSESS ICH)
Actual Study Start Date : May 23, 2023
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  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 [ 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).



Biospecimen Retention:   Samples With DNA
Complete Blood Count, Ribonucleic Acid, Deoxyribonucleic Acid

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05611918


Locations
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Sponsors and Collaborators
Johns Hopkins University
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Wendy Ziai, MD Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT05611918    
Other Study ID Numbers: IRB00311985
R01NS120557 ( U.S. NIH Grant/Contract )
First Posted: November 10, 2022    Key Record Dates
Last Update Posted: May 24, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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."
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Intracerebral hemorrhage
Stroke
Cognitive Impairment
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Cognitive Dysfunction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Pathologic Processes
Intracranial Hemorrhages