The Repeated Assessment of Survivors in ICH (REASSESS ICH)
Bradley N. Bohnstedt, MD
Primary Investigator
Brief description of 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.. 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 of study
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.
- To determine if surgical clot reduction after ICH reduces the risk of progressive cognitive decline.
- To determine if there is a long-term benefit in survival and functional outcome from minimally invasive surgery whether or not cognitive decline occurs
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Blood Clot, Cognitive Decline, Cognitive Impairment, Memory Impairment, Stroke, Intracerebral Hemorrhage
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Age: 18 years - 100 years
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Gender: All
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
contacted to capture relevant data.
• MIS and non-surgical ICH patients treated at participating sites in the REASSESS study with a prior history of
supratentorial spontaneous primary ICH with volume greater than 30mL and the following inclusion criteria.
o Age greater than 18 years
o Glasgow Coma Score (GCS) 5-14
o Survival greater than 6 months after ICH
o Historical Modified Rankin Score 0 or 1
EXCLUSION CRITERIA:
For MRI Sub-study only:
• Contraindications to MRI such as claustrophobia, metal implants, or pacemaker.