The Repeated Assessment of Survivors in ICH (REASSESS ICH)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 350
- 试验地点
- 52
- 主要终点
- To determine if surgical clot reduction after ICH reduces the risk of progressive cognitive decline.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
To determine if surgical clot reduction after ICH reduces the risk of progressive cognitive decline.
时间窗: 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.
次要结局
- 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)