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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 13, 2024
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date November 3, 2022
First Posted Date November 10, 2022
Last Update Posted Date May 13, 2024
Actual Study Start Date May 23, 2023
Estimated Primary Completion Date September 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 3, 2022)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 3, 2022)
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).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title REpeated ASSEssment of SurvivorS in Intracerebral Hemorrhage Study
Official Title The Repeated Assessment of Survivors in ICH (REASSESS ICH)
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Complete Blood Count, Ribonucleic Acid, Deoxyribonucleic Acid
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.
Condition
  • Intra Cerebral Hemorrhage
  • ICH - Intracerebral Hemorrhage
  • ICH
  • Hemorrhage
  • Stroke
  • Clot (Blood); Brain
  • Clot Blood
  • Cognitive Decline
  • Cognitive Impairment
  • Survivorship
  • Memory Impairment
  • Motor Activity
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: November 3, 2022)
350
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2027
Estimated Primary Completion Date September 1, 2025   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05611918
Other Study ID Numbers IRB00311985
R01NS120557 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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.
Current Responsible Party Johns Hopkins University
Original Responsible Party Same as current
Current Study Sponsor Johns Hopkins University
Original Study Sponsor Same as current
Collaborators National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Wendy Ziai, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date May 2024