Neurocognitive Impairment Assessment in Symptomatic Carotid Occlusion Recanalized Endovascularly: NIA SCORE
Neurocognitive Impairment Assessment in Symptomatic Carotid Occlusion Recanalized Endovascularly: NIA SCORE
批准号:
10634259
负责人:
David M. Hasan
金额:
$114.78万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2020
资助国家:
美国
项目状态:
未结题
起止时间:
2020-04-15 至 2025-03-31
关键词:
AdultAffectAgeAlzheimer&aposs DiseaseAmygdaloid structureAnatomyAngiographyAngioplastyAreaArteriesAtherosclerosisBiological MarkersBlood VesselsBlood flowBypassCaliberCarotid ArteriesCarotid EndarterectomyCerebrovascular CirculationCerebrumCervicalClassificationClinicalClinical TrialsCognitiveCreatineDataDementiaDevelopmentEnrollmentFailureHippocampus (Brain)HybridsImpaired cognitionIncidenceInternal carotid artery structureInterventionIpsilateralIschemic StrokeLesionLimbic SystemMagnetic Resonance ImagingMeasuresMedicalMeta-AnalysisMethodsMinorN-acetylaspartateNatural HistoryNeurocognitive DeficitNeuropsychologyOutcomeOutcome MeasureOxygenPatientsPerfusionPhasePilot ProjectsRandomizedRecording of previous eventsRecurrenceResolutionRiskRuptureSpectrum AnalysisStentsStrokeTechniquesTestingTimeTransient Ischemic AttackVascular Dementiaarmartery occlusionbasecerebral blood volumecognitive functioncognitive testingcohortexecutive functionhuman dataimprovedmaleopen labelprospectiveradiological imagingsafety and feasibilityspecific biomarkerssuccess
中文摘要
项目总结:
动脉粥样硬化性疾病引起的颈内动脉完全闭塞
约15%-25%的缺血性卒中分布在颈动脉。此外,40%的受试者
患有短暂性脑缺血发作的COICA和70%患有中风的COICA
随着时间的推移,认知能力下降,患血管性痴呆症和阿尔茨海默病的风险显著增加。
我们小组和其他人使用了另一种方法来用COICA重新血管化受试者。这些
研究表明使用血管内成形术和支架置入术(EAS)和/或混合血管成形术和/或混合术的可行性和安全性
颈动脉肠切除术(CEA)和EAS以恢复脑血流至同侧COICA半球。
此外,我们的团队设计了一种新的血管造影和解剖分类来预先预测成功
使用这些技术进行血运重建。这一分类在两个试点研究中进行了测试,结果
显示出强大的似是而非的能力来预先预测这些血管重建的预期成功率
使用这些技术的损伤。此外,包括我们在内的3个小组显示,使用这些
技术恢复脑血流至同侧COICA半球,明显的正常化
CT灌注的平均瞬时时间(MTT值)和认知功能明显改善。
EAS和混合技术恢复了颈内动脉的口径,从而使所有人的血液流动
受累血管CTP半影区完全消退,MTT值正常化。
这可能为认知功能的显著改善提供了解释。
对这一队列的最佳医疗管理可能足以降低中风复发和/或
TIA,但不足以改善执行和认知功能,并将血管加速风险降至最低
痴呆症和阿尔茨海默病随时间推移。这造成了临床上的差距,必须有替代的方法来帮助这一点
一群人。因此,我们利用我们的数据和其他数据来检验以下主要假设:
基本假设:使用血管内技术(或混合技术)对症状性COICA进行血运重建
颈动脉内膜剥脱术和血管内技术)将显著改善认知结果。
为了验证这一假设,我们将检查以下目标:
主要目的:验证血管内血运重建术改善COICA的假说
蒙特利尔认知评估(MoCA)测验测量显著认知功能。
次要目标:检验有症状的COICA和轻度/中度受试者
认知功能障碍有以下生物标志物:a)大的半影区(≥50毫升)通过错配测量
脑血流量(CBF)及CTP、B)乳酸和N-乙酰天冬氨酸减少的四甲基偶氮唑盐比色法
对分水岭区域(特别是半卵圆中心)的肌酸(Naa/Cr)进行磁共振波谱分析,以及C)
核磁共振显示海马体和杏仁核体积减少。
英文摘要
Project Summary:
Complete occlusion of the internal carotid artery (COICA) by atherosclerotic disease causes
approximately 15%–25% of ischemic strokes in the carotid artery distribution. Additionally, 40% of subjects
with COICA who present with transient ischemic attacks and 70% of COICA who present with stroke have
cognitive decline with significantly increased risk of vascular dementia and Alzheimer's' disease with time.
Our group and others have used an alternative approach to revascularize subjects with COICAs. These
studies showed the feasibility and safety of using endovascular angioplasty and stenting (EAS) and/or hybrid of
both carotid enterectomy (CEA) and EAS to restore cerebral flow to the ipsilateral hemisphere of the COICA.
Furthermore, our group devised a new angiographic and anatomic classification to upfront predict the success
of revascularization using these techniques. This classification was tested in 2 pilot studies and the results
showed robust plausibility to predict upfront the percentage of success anticipated in revascularizing these
lesions using these techniques. In addition, 3 groups including ours showed that revascularization using these
techniques restored cerebral blood flow to the ipsilateral hemisphere of the COICA evident of normalization of
mean transient time (MTT) on CT perfusion (CTP) and significant improvement in the cognitive function.
EAS and hybrid technique restore the caliber of the cervical ICA and therefore, the blood flow to all
involved vessels with clear evidence of complete resolution of penumbra and normalization of MTT on CTP.
This could provide an explanation for the marked improvement of cognitive function.
Best medical management for this cohort maybe sufficient to reduce the risk of recurrent strokes and/or
TIAs but not enough to improve executive and cognitive function and minimize the accelerated risk of vascular
dementia and AD with time. This creates a clinical gap and a must need of an alternative approach to help this
cohort. Therefore, we leverage our data and others to test the primary hypothesis below:
Primary Hypothesis: Revascularizing symptomatic COICA using endovascular techniques (or Hybrid
of carotid endarterectomy and endovascular techniques) will significantly improve cognitive outcome.
To test this hypothesis we will examine these objectives:
Primary Objective: To test the hypothesis that endovascular revascularization of COICA improves
significantly cognitive function measured by Montreal Cognitive Assessment (MoCA) test.
Secondary Objectives: To test the hypothesis that subjects with symptomatic COICAs and mild/moderate
cognitive dysfunction have the following biomarkers: A) Large penumbra (≥50 ml) measured by mismatch
volume of cerebral blood flow (CBF) & MTT on CTP, B) Presence of lactate and decreased N-acetylaspartate
to creatine (Naa/Cr) in the watershed area (specifically centrum semiovale) on MRI-spectroscopy, and C)
Decreased volumes of the hippocampus and amygdala on MRI.
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海外基金