The Repeated Assessment of Survivors in ICH (REASSESS ICH)

B
Bradley N. Bohnstedt, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
All
Phase N/A
6 participants needed
2 Locations

Brief description of study

What will happen during the 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.

THIS STUDY IS ENROLLING BY INVITATION ONLY - IU study team will contact participants in the previously completed clinical trial (ENRICH IU Protocol #: 1610661901) and ask them to participate in this multicenter observational trial. 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. 

Detailed description of study

What will happen during the study?
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.
 

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.

PRIMARY OUTCOME MEASURE:
  • To determine if surgical clot reduction after ICH reduces the risk of progressive cognitive decline.
SECONDARY 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
 
 

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
  • Age: 18 years - 100 years
  • 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.

Updated on 28 Jan 2025. Study ID: SNEU-JHOPKINS-REASSESS, 24405
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