Field Core (Core B)

现场核心（核心 B）

基本信息

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
项目类别：
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&apos 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

项目摘要

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摘要该计划项目（P01）题为“谵妄、痴呆和弱势大脑：综合性研究” 方法”试图通过一种方法来定义谵妄、痴呆和大脑脆弱性之间的复杂关系。由五个相互关联的项目组成的系列，每个项目都会检查漏洞的一个独特方面。支持所有项目并具有以下具体目标：目标 1：对原始选择性手术后成功衰老 (SAGES I) 队列进行免费评估基线时痴呆症的发生率 (N=560)，确保尽可能高的参与者保留率和研究的完整性活动包括： 1) 对于整个 SAGES I 队列，完成两波长期随访。访谈：第一波（1-3 年）将确保至少 5 年的随访时间，第二波（第 3-5 年）将确保至少 8 年的随访；2) 邀请 128 名 SAGES I 参与者，概率根据入院谵妄状态指数和频率进行抽样，并与年龄和基线认知相匹配状态，返回医院进行详细评估，包括通过以下方式收集脑脊液 (CSF)：用于阿尔茨海默病 (AD) 的腰椎穿刺 (LP) 和炎症生物标志物测量，用于治疗的静脉切开术血浆 AD 和炎症标志物测量、磁共振成像 (MRI) 研究，以及经颅磁刺激（TMS）-脑电图（EEG）研究。目标 2：建立一个名为 SAGES II 的新队列，其中包含 400 名接受全髋关节或膝关节置换术的患者在两个学术医疗中心贝斯以色列女执事医疗中心 (BIDMC) 和布莱根妇女医院 (BWH)，并对这一队列进行为期 18 个月的跟踪，并将随访时间延长至 36 人与 SAGES II 队列相关的活动包括：1) 识别、接触和招募符合条件的人员。目标是实现尽可能高的参与度的患者；2) 在之前进行基线评估手术、住院期间每天进行谵妄评估以及随访术后 1、2、6、12、18 个月进行评估，并在 24 和 36 个月时进行长期随访3)；通过收集 AD 的脑脊液和血液样本，为每个组成项目提供专门支持和炎症生物标志物测量，以及转诊患者进行 MRI、TMS 和 EEG 研究。目标 3：雇用、培训和监督所有现场工作人员的活动，确保各方面的协调 SAGES I 和 II 队列研究包括研究参与者的安全性和高质量数据收集。通过执行这些目标，现场核心将在该计划的各个方面发挥重要作用该项目将定义谵妄、痴呆和大脑脆弱性之间的复杂关系。在第一个融资周期中，我们已经非常成功地实现了所有目标。实施相同的原则和程序，雇用许多相同的领导者和现场团队人员这种连续性确保了持续成功的极高可能性。