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
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Sponsor:
Johns Hopkins University
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Johns Hopkins University
Tracking Information | |||||||||||||||||
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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 |
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.
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Original Primary Outcome Measures | Same as current | ||||||||||||||||
Change History | |||||||||||||||||
Current Secondary Outcome Measures |
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).
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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 |
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Target Follow-Up Duration | Not Provided | ||||||||||||||||
Biospecimen | Retention: Samples With DNA Description: Complete Blood Count, Ribonucleic Acid, Deoxyribonucleic Acid
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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 |
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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. |
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Recruitment Information | |||||||||||||||||
Recruitment Status | Enrolling by invitation | ||||||||||||||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 ) |
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Has Data Monitoring Committee | No | ||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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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 |
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PRS Account | Johns Hopkins University | ||||||||||||||||
Verification Date | May 2024 |