ARCADIA CSI (Cognition and Silent Infarcts)

ARCADIA CSI（认知和无症状梗塞）

基本信息

批准号：
10450768
负责人：
MAARTEN G LANSBERG
金额：
$ 20.86万
依托单位：
STANFORD UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-07-01 至 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10450768
关键词：
Address Affect American Ancillary Study Anticoagulants Anticoagulation Aspirin Atrial Fibrillation Blinded Brain Infarction Brain scan Caregivers Certification Clinical Cognition Cognitive Dementia Deterioration Eligibility Determination Enrollment Foundations Future Health Care Costs Health Professional Heart Atrium Image Impaired cognition Incidence Individual Infarction Infrastructure Language Left MRI Scans Magnetic Resonance Imaging Modeling National Institute of Neurological Disorders and Stroke Neurocognitive Neuropsychological Tests Outcome Outcome Measure Parents Patients Persons Prevention Public Health Qualifying Quality of life Randomized Recording of previous events Recurrence Relative Risks Research Research Priority Risk Risk Reduction Side Stroke Surveys Telephone Testing Time United States Visit arm cognitive change cognitive function cognitive testing cryptogenic stroke dementia risk design effective therapy follow-up high risk improved insight mild cognitive impairment post stroke post stroke cognitive impairment post stroke dementia prevent prospective rate of change relapse prevention response routine care stroke cognitive outcome stroke patient stroke survivor telephone based time interval treatment arm treatment comparison treatment effect trend

项目摘要

Project Summary: Cognitive decline and dementia after stroke is a major public health problem, with risk of dementia more than doubling after stroke and affecting more the 2 million people in the United States alone. Yet, there are no effective treatments to prevent cognitive decline and dementia after stroke. Silent brain infarction has been associated with cognitive decline, especially among those at high risk for cardio-embolism. It is therefore likely that treatments that reduce the incidence of silent infarcts in stroke patients at high risk for cardio-embolism, will also reduce the rate of cognitive decline and dementia. To test this, we propose to conduct an ancillary study to the NINDS-sponsored ARCADIA trial. ARCADIA compares treatment with apixaban versus aspirin to prevent a recurrent clinical stroke in patients with cryptogenic stroke and left atrial cardiopathy. We are taking advantage of the parent trial to address the possibility that apixaban might also reduce the incidence of silent infarction and be associated with better cognitive function over time compared to aspirin. We will enroll 500 patients from the 1,100 that will participate in ARCADIA. Patients who participate in the ancillary study (ARCADIA-CSI) will receive cognitive assessments at baseline and yearly thereafter using a telephone-based cognitive battery. We will test the hypothesis that the slope of change in cognitive function is less steep in patients on apixaban compared to patients on aspirin therapy. We will also collect an initial MRI around the time of the qualifying stroke and a follow-up MRI at the time that the subject completes participation in the ARCADIA parent study. Based on these two MRI scans we will assess the incidence of new silent infarcts during the follow-up period and test the hypothesis that apixaban treatment results in a reduction of the percentage of patients with silent infarcts compared to aspirin therapy. An explorative analysis will also look for the relationship between new silent infarcts and cognitive change. Our project will be among the first to determine prospectively the impact of silent infarction on cognitive function. And, if cognitive decline can be ameliorated by apixaban, then we will have established the first ever treatment for the prevention of post-stroke cognitive decline.

项目概要：中风后认知能力下降和痴呆是一个重大的公共卫生问题，患痴呆症的风险更大中风后发病率增加了一倍以上，仅在美国就有超过 200 万人受到影响。然而，有没有有效的治疗方法可以预防中风后认知能力下降和痴呆。无症状脑梗塞与认知能力下降有关，尤其是那些心源性栓塞高危人群。这是因此，降低中风高风险患者无症状梗死发生率的治疗可能心源性栓塞，还会降低认知能力下降和痴呆的发生率。为了测试这一点，我们建议对 NINDS 赞助的 ARCADIA 试验进行辅助研究。 ARCADIA 将治疗与阿哌沙班与阿司匹林对比，预防隐源性中风和左脑卒中患者复发性临床中风心房性心脏病。我们正在利用家长试验来解决阿哌沙班可能还可以降低无症状梗塞的发生率，并随着时间的推移与更好的认知功能相关与阿司匹林相比。我们将从参与 ARCADIA 的 1,100 名患者中招募 500 名。患者参加辅助研究 (ARCADIA-CSI) 的人将接受基线认知评估，此后每年使用基于电话的认知电池。我们将检验以下假设：与接受阿司匹林治疗的患者相比，接受阿哌沙班治疗的患者认知功能的变化不太明显。我们还将在合格中风发生时收集初始 MRI 数据，并在当时收集后续 MRI 数据受试者完成 ARCADIA 家长研究的参与。根据这两次 MRI 扫描，我们将评估随访期间新的无症状梗塞的发生率并检验以下假设：与阿哌沙班治疗相比，无症状梗塞患者的百分比有所降低阿司匹林疗法。探索性分析还将寻找新的无症状梗塞与认知改变。我们的项目将是第一个前瞻性地确定静音影响的项目之一梗塞对认知功能的影响。而且，如果阿哌沙班可以改善认知能力下降，那么我们将建立了有史以来第一个预防中风后认知能力下降的治疗方法。