Field Core (Core B)

现场核心（核心 B）

• 批准号: 10405115
• 负责人: EDWARD R MARCANTONIO
• 金额: $ 38.58万
• 依托单位: HEBREW REHABILITATION CENTER FOR AGED
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-15 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10405115
• 关键词: Academic Medical Centers; Admission activity; Adverse event; Age; Aging; Alzheimer' s Disease; Alzheimer’s disease biomarker; Biological Markers; Blood; Blood specimen; Brain; Cerebrospinal Fluid; Clinical; Code; Cognitive; Cohort Studies; Collaborations; Collection; Complex; Data Collection; Delirium; Dementia; Diagnosis; Disease Marker; Elderly; Electroencephalography; Enrollment; Ensure; Evaluation; Frequencies; Funding; Goals; Hospitalization; Hospitals; Inflammatory; Interview; Israel; Logistics; Longterm Follow-up; Magnetic Resonance Imaging; Manuals; Measurement; Medical center; Monitor; Neurology; Operative Surgical Procedures; Participant; Patients; Plasma; Play; Postoperative Period; Probability Samples; Procedures; Reporting; Role; Safety; Sampling; Schedule; Series; Spinal Anesthesia; Spinal Puncture; Structure; Time; Total Hip Replacement; Training; Transcranial magnetic stimulation; Venous blood sampling; Woman; Work; base; cohort; comorbidity; follow up assessment; follow-up; human subject; imaging study; indexing; inflammatory marker; knee replacement arthroplasty; meetings; member; older patient; operation; participant retention; participant safety; programs; quality assurance; recruit; success

CORE B ABSTRACT The Program Project (P01) entitled “Delirium, Dementia and the Vulnerable Brain: An Integrative Approach” seeks to define the complex relationship of delirium, dementia, and brain vulnerability through a series of five, interrelated projects, each of which examines a unique aspect of vulnerability. The Field Core will support all of the projects and has the following Specific Aims: Aim 1: To perform assessments on the original Successful Aging after Elective Surgery (SAGES I) cohort free of dementia at baseline (N=560), ensuring the highest possible participant retention and completeness of study variables. Activities include: 1) For the entire SAGES I cohort, completing two waves of long-term follow-up interviews: the first wave (years 1-3) will ensure a minimum of 5 years of follow-up, and the second wave (years 3-5) will ensure a minimum of 8 years of follow-up; 2) Inviting 128 SAGES I participants, probability sampled based on their index admission delirium status and frequency matched by age and baseline cognitive status, to return to the hospital for a detailed evaluation, including cerebrospinal fluid (CSF) collection via lumbar puncture (LP) for Alzheimer's Disease (AD) and inflammatory biomarker measurement, phlebotomy for plasma AD and inflammatory marker measurement, magnetic resonance imaging (MRI) studies, and transcranial magnetic stimulation (TMS)-electroencephalography (EEG) studies. Aim 2: To accrue a new cohort, called SAGES II, of 400 patients undergoing total hip or knee replacements under spinal anesthesia at two academic medical centers, Beth Israel Deaconess Medical Center (BIDMC) and Brigham and Women's Hospital (BWH), and to follow this cohort for 18 months with extended follow-up to 36 months. Activities related to the SAGES II cohort include: 1) identifying, approaching, and enrolling eligible patients with a goal of achieving the highest possible participation; 2) performing baseline assessments prior to surgery, in-hospital assessments for delirium daily throughout the index hospitalization, and follow-up assessments at 1, 2, 6, 12, 18, months after surgery, with extended follow-up at 24 and 36 months; 3) providing specialized support for each of the component projects by collecting CSF and blood samples for AD and inflammatory biomarker measurement, and referring patients for MRI, TMS, and EEG studies. Aim 3: To hire, train, and monitor the activities of all field staff, ensuring coordination of all aspects of the SAGES I and II cohort studies including study participant safety, and high quality data collection. Through execution of these Aims, the Field Core will play an essential role in all aspects of the Program Project, which will define the complex relationship of delirium, dementia, and brain vulnerability. The Field Core has been highly successful in achieving all of its Aims in the first funding cycle. In the renewal, we will implement the same principles and procedures, employ many of the same leaders and field team staff members. This continuity ensures a very high likelihood of continued success.

核心B摘要 计划项目（P01）名为“ del妄，痴呆和脆弱的大脑：综合性 方法”旨在通过一个 五个相互关联的项目系列，每个项目都研究了脆弱性的独特方面。场核将 支持所有项目，并具有以下具体目标： 目标1：对选修手术后的原始成功衰老（SAGES I）进行免费评估 基线时的痴呆症（n = 560），确保可能的参与保留率最高和研究的完整性 变量。活动包括：1）在整个圣人我队列中，完成了两波长期随访的波 访谈：第一波（1 - 3年）将确保至少5年的随访，第二波 （3 - 5年）将确保至少8年的随访； 2）邀请128个圣人我参与者，概率 根据年龄和基线认知匹配的索引入学ir妄状态和频率进行采样 状态，返回医院进行详细评估，包括脑脊液（CSF）通过 阿尔茨海默氏病（AD）和炎症生物标志物测量的腰椎穿刺（LP） 等离子体AD和炎症标记测量，磁共振成像（MRI）研究和 经颅磁刺激（TMS） - 电脑术（EEG）研究。 AIM 2：为400名接受总髋关节或膝关节置换的患者的新队列，称为Sages II 在两个学术医疗中心的脊柱麻醉下，贝丝以色列执事医疗中心（BIDMC）和 Brigham and妇女医院（BWH），并跟随该同伙进行18个月，延长后续行动至36个 月份。与圣人II队列相关的活动包括：1）识别，接近和招募合格的活动 目标是达到最高参与的目标； 2）在进行之前进行基线评估 在整个指数住院期间，手术，每天del妄的院内评估以及随访 在手术后1、2、6、12、18的评估，在24和36个月时进行了延长的随访； 3） 通过为AD收集CSF和血液样本为每个组件项目提供专门的支持 以及炎症性生物标志物测量，并参考患者进行MRI，TMS和EEG研究。 目标3：雇用，培训和监视所有现场工作人员的活动，以确保协调的各个方面 SAGES I和II队列研究包括研究参与者的安全和高质量的数据收集。 通过执行这些目标，现场核心将在程序的各个方面发挥重要作用 项目将定义del妄，痴呆和大脑脆弱性的复杂关系。场核 在第一个融资周期中实现了所有目标，一直非常成功。在续约中，我们将 实施相同的原则和程序，员工，许多相同的领导者和现场团队工作人员 成员。这继续确保持续成功的可能性很高。