REpeated ASseSsmEnt of SurvivorS in ICH (REASSESS ICH)

ICH 幸存者的重复评估 (REASSESS ICH)

基本信息

批准号：
10545055
负责人：
Matthew Flaherty
金额：
$ 179.94万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-01-01 至 2026-12-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10545055
关键词：
Acceleration Acute Address Age Alteplase Automobile Driving Biological Process Cerebral Amyloid Angiopathy Cerebral hemisphere hemorrhage Chronic Clinical Clinical Trials Coagulation Process Cognitive Complex Data Dementia Dependence Encephalitis Enrollment Ethnic Origin Excision Follow-Up Studies Funding Gene Expression Genes Genotype Hematoma Hemorrhage Hispanic Impaired cognition Incidence Inflammation Inflammatory Injury Ischemic Stroke Leukoaraiosis Lobar Location Longitudinal Studies Longterm Follow-up Methodology Observational Study Operative Surgical Procedures Outcome Outcome Assessment Outcome Study Participant Pathway interactions Patients Performance Persons Race Randomized, Controlled Trials Reporting Residual state Residual volume Resources Risk Risk Factors Risk Reduction Site Stroke Structure Suggestion Supratentorial Survivors Target Populations Techniques Telephone Interviews Testing Time United States National Institutes of Health Variant Visit White Matter Disease aging brain arm comparative cost effective design disability follow-up functional disability functional outcomes high risk hypertension treatment improved interest life time cost minimally invasive mortality mortality risk neuropsychiatry novel participant enrollment prospective recruit response risk prediction risk variant sex standard care standard of care stroke survivor survival outcome treatment strategy

项目摘要

Project Summary / Abstract Purpose: The REpeated ASSEssment of SurvivorS in ICH 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 recently completed MISTIE III and ENRICH trials, and the current standard of care using data from both 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 the cases with serial cognitive examinations. Rationale: Intracerebral hemorrhage has the highest disability rate among stroke survivors. ICH survivors are at particularly high risk for progressive cognitive impairment which is strongly associated with greater hematoma volume, but also with cerebral amyloid angiopathy. Compared with standard of care, minimally invasive surgery with effective hematoma volume reduction may improve long-term functional outcomes while also reducing mortality. As such, reducing hematoma volume after ICH may reduce the risk of post ICH cognitive decline. Design: REASSESS ICH is a longitudinal structured serial telephone interview follow-up plus one-time in- person visit of an anticipated 359 ICH survivors enrolled in MISTIE III (2013-2017) or ENRICH (2018-2022). Cognitive and functional outcome data will be compared with up to 900 patients enrolled in ERICH-L, to determine if surgical ICH reduction leads to reduced risk of progressive cognitive decline. Primary Aim 1: To determine if surgical clot reduction after ICH reduces the risk of progressive cognitive decline. Hypothesis: The final residual volume of ICH will correlate with risk of cognitive decline after controlling for age, sex, initial volume of ICH, leukoaraiosis, APOE genotype, and hypertension treatment among operated and non-operated survivors of MISTIE III/ENRICH and survivors of ERICH, and effective clot reduction (<20 mL end of treatment volume), will be associated with lower risk of cognitive decline compared to non-operated patients. Primary Aim 2: To determine if there is a long-term benefit in survival and functional outcome from minimally invasive surgery and the interaction with cognitive decline. Hypothesis: Effective clot reduction will be associated with a decreased risk of death/major disability compared to non-operated patients. Exploratory Aim 3: To determine if inflammatory gene pathway expression predicts risk of cognitive decline. Hypothesis: Chronic brain inflammation contributes to progressive cognitive impairment post ICH. Our preliminary data identifies that inflammation appears to occur chronically after ICH; not just acutely. When testing a wide variety of gene expression changes, the context of which pathway is involved is critical to provide context. We will evaluate whether inflammatory pathways in particular predict patients with cognitive impairment independent of gene risk scores for dementia and surgical status.

项目概要/摘要目的：ICH研究中幸存者的重复评估将进行长期的认知、功能、和神经精神性能评估，以确定是否自发性脑内排空出血（ICH）可降低衰老大脑后期认知能力下降的风险。这项研究将比较比率两种脑出血治疗策略下认知能力下降的影响：使用微创使用最近完成的 MISTIE III 和 ENRICH 试验中执行的两种类似技术进行的手术，以及使用来自 MISTIE III 和 ENRICH 中两个对照的数据以及比较数据的当前护理标准从 ICH (ERICH) 研究 (U-01-NS067963) 扩展到 ERICH- 纵向研究 (R01-NS093870) 对 900 多个病例进行了系列认知检查。理由：脑出血在中风幸存者中致残率最高。 ICH 幸存者是进行性认知障碍的风险特别高，这与更大的认知障碍密切相关血肿量大，也与脑淀粉样血管病有关。与标准护理相比，至少有效减少血肿量的侵入性手术可以改善长期功能结果，同时还降低死亡率。因此，减少 ICH 后的血肿量可能会降低 ICH 后的风险认知能力下降。设计：REASSESS ICH 是一种纵向结构化系列电话访谈随访以及一次性访谈对参加 MISTIE III（2013-2017 年）或 ENRICH（2018-2022 年）的预计 359 名 ICH 幸存者进行个人访问。认知和功能结果数据将与 ERICH-L 中登记的多达 900 名患者进行比较，以确定手术减少脑出血是否会降低进行性认知能力下降的风险。主要目标 1：确定 ICH 后手术减少血栓是否可以降低进行性认知障碍的风险衰退。假设：ICH 的最终残余量与控制后认知能力下降的风险相关手术患者的年龄、性别、初始 ICH 量、脑白质疏松、APOE 基因型和高血压治疗情况和 MISTIE III/ENRICH 的非手术幸存者和 ERICH 的幸存者，以及有效的血栓减少（<20 与非手术治疗相比，认知能力下降的风险较低患者。主要目标 2：确定最低限度的治疗是否对生存和功能结果有长期益处侵入性手术以及与认知能力下降的相互作用。假设：有效减少血栓与未手术患者相比，死亡/严重残疾风险降低。探索性目标 3：确定炎症基因通路表达是否可以预测认知能力下降的风险。假设：慢性脑炎症会导致脑出血后进行性认知障碍。我们的初步数据表明，ICH后炎症似乎会长期发生；不仅仅是剧烈地。什么时候测试各种基因表达变化，涉及哪种途径的背景对于提供上下文。我们将评估炎症通路是否特别能预测认知障碍患者与痴呆和手术状态的基因风险评分无关的损害。