ICH03: REpeated ASSEssment of SurvivorS in Intracerebral Hemorrhage Study

Sponsor

Johns Hopkins University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05611918

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

350

Enrollment

Locations

58.9

Anticipated Duration (Months)

13.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intra Cerebral Hemorrhage ICH - Intracerebral Hemorrhage ICH Hemorrhage Stroke Clot (Blood); Brain Clot Blood Cognitive Decline Cognitive Impairment Survivorship Memory Impairment Motor Activity

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 Design

Study Type:

Observational

Anticipated Enrollment :

350 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

The Repeated Assessment of Survivors in ICH (REASSESS ICH)

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Dec 31, 2027

Outcome Measures

Primary Outcome Measures

To determine if surgical clot reduction after ICH reduces the risk of progressive cognitive decline. [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.

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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Brimingham	Birmingham	Alabama	United States	35294
2	Scripps Health	La Jolla	California	United States	92037
3	Dignity Health component - St. Joseph's Hospital and Medical Center	Sacramento	California	United States	95819
4	Stanford University	Stanford	California	United States	94305
5	Yale University	New Haven	Connecticut	United States	06511
6	Mayo Clinic, Jacksonville	Jacksonville	Florida	United States	32224
7	CommonSpirit (formerly Mercy San Juan Medical Center; dignity health)	Chicago	Illinois	United States	60606
8	University of Illinois at Chicago	Chicago	Illinois	United States	60607
9	University of Kansas Medical Center	Fairway	Kansas	United States	66205
10	University of Louisville	Louisville	Kentucky	United States	40292
11	University of Maryland Baltimore	Baltimore	Maryland	United States	21201
12	Johns Hopkins Hospital	Baltimore	Maryland	United States	21205
13	University of Michigan	Ann Arbor	Michigan	United States	48109
14	Henry Ford Health System	Detroit	Michigan	United States	48202
15	Hennepin Healthcare Research Institute	Minneapolis	Minnesota	United States	55415
16	Washington University in St. Louis, School of Medicine	Saint Louis	Missouri	United States	63130
17	Rutgers - Robert Wood Johnson Medical School	Piscataway	New Jersey	United States	08854
18	University of New Mexico	Albuquerque	New Mexico	United States	87131
19	Albert Einstein Montefiore	Bronx	New York	United States	10461
20	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
21	University of Cincinnati	Cincinnati	Ohio	United States	45220
22	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
23	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
24	University of Texas, Houston Health Science Center	Houston	Texas	United States	77030
25	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229
26	Inova Health System Foundation	Fairfax	Virginia	United States	22042