REpeated ASseSsmEnt of SurvivorS in ICH (REASSESS ICH)

ICH 幸存者的重复评估 (REASSESS ICH)

• 批准号: 10366955
• 负责人: Matthew Flaherty
• 金额: $ 111.78万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 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/10366955
• 关键词: 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; Excision; Follow-Up Studies; Funding; Gene Expression; Genes; Genotype; Hematoma; 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; Randomized Controlled Trials; Reporting; Residual state; Residual volume; Resources; Risk; Risk Factors; Site; Stroke; Structure; Suggestion; Supratentorial; Survivors; Target Populations; Techniques; Telephone Interviews; Testing; Time; United States National Institutes of Health; Variant; Visit; 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; prospective; racial and ethnic; recruit; response; risk variant; sex; standard care; standard of care; stroke survivor; survival outcome; treatment strategy; white matter

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.

项目总结/摘要 目的：ICH研究中存活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 脑出血（ICH）降低了衰老大脑中后期认知能力下降的风险。这项研究将比较利率 两种脑出血治疗策略下认知功能下降的研究：使用微创 采用与最近完成的MISTIE III和ENRICH试验相似的两种技术进行手术，以及 使用MISTIE III和ENRICH中对照数据和比较数据的现行标准治疗 从ICH的种族/人种差异（ERICH）研究（U-01-NS 067963）扩展到ERICH- 纵向研究（R 01-NS 093870）对900多例病例进行了一系列认知检查。 原理：脑出血在卒中幸存者中的致残率最高。ICH幸存者 进行性认知障碍的风险特别高，这与更大的 血肿体积大，还伴有脑淀粉样血管病。与标准治疗相比， 有效减少血肿体积的侵入性手术可改善长期功能结局， 也降低了死亡率。因此，减少ICH后血肿体积可降低ICH后风险 认知能力下降 设计：REASSESS ICH是一项纵向结构化的系列电话访谈随访加一次性的 对MISTIE III（2013-2017）或ENRICH（2018-2022）中预期入组的359名ICH幸存者进行了个人访视。 认知和功能结局数据将与入组ERICH-L的多达900例患者进行比较， 确定手术减少ICH是否会降低进行性认知能力下降的风险。 主要目的1：确定ICH后手术凝块减少是否可降低进行性认知功能障碍的风险 下降假设：ICH的最终残留量将与控制后认知能力下降的风险相关 年龄、性别、脑出血初始体积、脑白质疏松、APOE基因型和高血压治疗 MISTIE III/ENRICH的未手术存活者和ERICH的存活者，以及有效的血凝块减少（<20 mL治疗结束体积），与非手术治疗相比， 患者 主要目的2：确定最低限度的手术是否对生存和功能结局有长期益处 侵入性手术以及与认知能力下降的相互作用。假设：有效的血凝块减少将 与非手术患者相比，与死亡/严重残疾风险降低相关。 探索性目的3：确定炎症基因通路表达是否可预测认知能力下降的风险。 假设：慢性脑炎症导致ICH后进行性认知障碍。我们 初步数据表明，炎症似乎是在ICH后慢性发生的，而不仅仅是急性的。当 测试各种各样的基因表达变化，其中涉及的途径的背景是至关重要的， 提供背景。我们将评估炎症通路是否特别能预测认知功能障碍患者。 损伤独立于痴呆和手术状态的基因风险评分。