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.
Brief Title
REpeated ASSEssment of SurvivorS in Intracerebral Hemorrhage Study
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Intra Cerebral Hemorrhage
ICH - Intracerebral Hemorrhage
ICH
Hemorrhage
Stroke
Clot (Blood); Brain
Clot Blood
Cognitive Decline
Cognitive Impairment
Survivorship
Memory Impairment
Motor Activity
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
* 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
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Intracerebral hemorrhage
Stroke
Cognitive Impairment
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT05611918
Org Class
Other
Org Full Name
Johns Hopkins University
Org Study Id
IRB00311985
Overall Status
Enrolling by invitation
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
The Repeated Assessment of Survivors in ICH (REASSESS ICH)
Primary Outcomes
Outcome Description
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.
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.
Outcome Measure
To determine if surgical clot reduction after ICH reduces the risk of progressive cognitive decline.
Outcome Time Frame
24 months
Secondary Ids
Secondary Id
R01NS120557
Secondary Outcomes
Outcome Description
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).
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).
Outcome Time Frame
24 months
Outcome Measure
To determine if there is a long-term benefit in survival and functional outcome from minimally invasive surgery whether or not cognitive decline occurs
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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.
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Rishi Malhotra
Investigator Email
rmalhotr@montefiore.org
Investigator Department
Neurology
Investigator Sponsor Organization
Einstein
Study Department
Medicine
Study Division
Critical Care Medicine
Categories Mesh Debug
Blood Disorders --- HEMORRHAGE
Brain, Spinal Cord & Nervous System --- STROKE
Brain, Spinal Cord & Nervous System --- THROMBOSIS
Alzheimer's --- COGNITIVE DYSFUNCTION
Brain, Spinal Cord & Nervous System --- CEREBROVASCULAR DISORDERS
Alzheimer's --- BRAIN DISEASES
Brain, Spinal Cord & Nervous System --- BRAIN DISEASES
Brain, Spine & Nerve Cancers --- BRAIN DISEASES
Alzheimer's --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Alzheimer's --- NEUROCOGNITIVE DISORDERS
Child Development & Autism --- MENTAL DISORDERS
Mental Health & Behavioral Research --- MENTAL DISORDERS
Psychiatry & Behavioral Sciences --- MENTAL DISORDERS
Substance Use and Addiction --- MENTAL DISORDERS
Mental Health & Behavioral Research --- NEUROBEHAVIORAL MANIFESTATIONS
Brain, Spinal Cord & Nervous System --- NEUROLOGIC MANIFESTATIONS
Headaches & Migraine --- NEUROLOGIC MANIFESTATIONS
Substance Use and Addiction --- NEUROLOGIC MANIFESTATIONS
MeSH Terms
CEREBRAL HEMORRHAGE
HEMORRHAGE
STROKE
INTRACRANIAL THROMBOSIS
THROMBOSIS
COGNITIVE DYSFUNCTION
MEMORY DISORDERS
MOTOR ACTIVITY
INTRACRANIAL HEMORRHAGES
CEREBROVASCULAR DISORDERS
BRAIN DISEASES
CENTRAL NERVOUS SYSTEM DISEASES
NERVOUS SYSTEM DISEASES
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
INTRACRANIAL EMBOLISM AND THROMBOSIS
THROMBOEMBOLISM
EMBOLISM AND THROMBOSIS
COGNITION DISORDERS
NEUROCOGNITIVE DISORDERS
MENTAL DISORDERS
NEUROBEHAVIORAL MANIFESTATIONS
NEUROLOGIC MANIFESTATIONS
SIGNS AND SYMPTOMS
BEHAVIOR