REpeated ASseSsmEnt of SurvivorS in ICH (REASSESS ICH)
REpeated ASseSsmEnt of SurvivorS in ICH (REASSESS ICH)
批准号:
10545055
负责人:
Matthew Flaherty
金额:
$179.94万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
未结题
起止时间:
2022-01-01 至 2026-12-31
关键词:
AccelerationAcuteAddressAgeAlteplaseAutomobile DrivingBiological ProcessCerebral Amyloid AngiopathyCerebral hemisphere hemorrhageChronicClinicalClinical TrialsCoagulation ProcessCognitiveComplexDataDementiaDependenceEncephalitisEnrollmentEthnic OriginExcisionFollow-Up StudiesFundingGene ExpressionGenesGenotypeHematomaHemorrhageHispanicImpaired cognitionIncidenceInflammationInflammatoryInjuryIschemic StrokeLeukoaraiosisLobarLocationLongitudinal StudiesLongterm Follow-upMethodologyObservational StudyOperative Surgical ProceduresOutcomeOutcome AssessmentOutcome StudyParticipantPathway interactionsPatientsPerformancePersonsRaceRandomized, Controlled TrialsReportingResidual stateResidual volumeResourcesRiskRisk FactorsRisk ReductionSiteStrokeStructureSuggestionSupratentorialSurvivorsTarget PopulationsTechniquesTelephone InterviewsTestingTimeUnited States National Institutes of HealthVariantVisitWhite Matter Diseaseaging brainarmcomparativecost effectivedesigndisabilityfollow-upfunctional disabilityfunctional outcomeshigh riskhypertension treatmentimprovedinterestlife time costminimally invasivemortalitymortality riskneuropsychiatrynovelparticipant enrollmentprospectiverecruitresponserisk predictionrisk variantsexstandard carestandard of carestroke survivorsurvival outcometreatment strategy
中文摘要
项目摘要/摘要
目的:在ICH研究中对幸存者的重复评估将进行长期的认知、功能、
和神经精神功能评估以确定自发性脑内排空
出血(ICH)降低了老化大脑中后来认知能力下降的风险。这项研究将比较
脑出血两种治疗策略下认知功能减退:微创治疗的使用
采用最近完成的Mistie III和Enrich试验中使用的两种类似技术的手术,以及
使用Mistie III中的两个对照数据和丰富和比较数据的当前护理标准
从非物质文化遗产的民族/种族变化研究(U-01-NS067963)延伸到埃里希-
纵向研究(R01-NS093870),对900多例进行系列认知检查的患者进行跟踪调查。
理论基础:脑出血是中风幸存者中致残率最高的。ICH幸存者是
进行性认知损害的风险特别高,这与
血肿量大,还伴有脑淀粉样血管病变。与护理标准相比,最低限度
有效缩小血肿体积的侵入性手术可能会改善长期功能结果
同时也降低了死亡率。因此,减少脑出血后血肿量可能会降低脑出血后的风险。
认知能力下降。
设计:重新评估ICH是一种纵向结构化的系列电话采访随访,外加一次性-
预计将有359名非物质文化遗产幸存者参加MISTIE III(2013-2017)或ENRICE(2018-2022)。
认知和功能结果数据将与埃里希-L研究中心登记的多达900名患者进行比较
确定手术治疗ICH是否会降低进行性认知功能衰退的风险。
主要目标1:确定脑出血后手术血栓减少术是否降低进行性认知风险
拒绝。假设:脑出血的最终残留量将与控制后认知功能下降的风险相关
手术患者的年龄、性别、脑出血初始体积、脑白质疏松、载脂蛋白E基因和高血压治疗
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(<;
治疗结束时),与非手术治疗相比,认知功能下降的风险较低
病人。
主要目标2:确定在生存和功能预后方面是否有长期益处。
侵入性手术与认知功能衰退的相互作用。假设:有效的血栓减少将是
与未做手术的患者相比,死亡/严重残疾的风险降低。
探索性目标3:确定炎性基因途径的表达是否预测认知功能衰退的风险。
假设:慢性脑炎症导致脑出血后进行性认知功能障碍。我们的
初步数据表明,炎症似乎在脑出血后慢性发生,而不仅仅是急性。什么时候
测试各种各样的基因表达变化,其中涉及哪条途径的上下文是至关重要的
提供背景信息。我们将评估炎症途径是否特别能预测认知障碍患者
损害与痴呆症和手术状态的基因风险评分无关。
英文摘要
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.
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REpeated ASseSsmEnt of SurvivorS in ICH (REASSESS ICH)
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批准号:10366955
-
项目类别:
-
资助金额:$111.78万
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财政年份:2022
-
负责人:Matthew Flaherty
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依托单位:
海外基金