The POINTER Neurovascular Ancillary Study

POINTER 神经血管辅助研究

基本信息

批准号：
10292584
负责人：
Tina E Brinkley
金额：
$ 12.78万
依托单位：
WAKE FOREST UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-04-15 至 2024-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10292584
关键词：
Address Administrative Supplement Advocate Ancillary Study Attention Baroreflex Blood Vessels Brain Brain imaging Budgets California Cerebrum Clinical Trials Clinical Trials Design Cognition Cognitive Data Data Collection Elderly Ensure Equipment Goals Grant Healthcare Homeostasis Infrastructure Monitor Outcome Parents Participant Procedures Quality Control Randomized Randomized Clinical Trials Resources Rhode Island Risk Sample Size Science Site Structure Techniques Transcranial Doppler Ultrasonography U-Series Cooperative Agreements United States National Institutes of Health Universities Vasomotor aged brain health cerebral hemodynamics cerebral vasomotor reactivity clinical research site cost data harmonization forest improved intervention effect lifestyle intervention medical schools neurovascular parent grant response

项目摘要

PROJECT SUMMARY Overview: This application is being submitted in response to PA-20-272 "Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)”. The purpose of this administrative supplement to R01 AG066910, entitled “The POINTER Neurovascular Ancillary Study” is to ensure that appropriate transcranial Doppler (TCD) ultrasound equipment and related supplies are available at all 5 participating sites in order to facilitate assessment of cerebral autoregulation and vasomotor reactivity. Participating sites include Wake Forest School of Medicine, Rush University, Advocate Health Care, University of California at Davis (UC Davis), and Rhode Island. The background/significance, specific aims/hypotheses, and approach (including experimental procedures, sample size, power estimates, and analytic plan) have not changed since the original application (i.e., no new science is being proposed). The present supplement will ensure robust and consistent data collection, enhanced quality control, and improved data harmonization across sites. Summary of Parent Grant: The U.S. study to PrOtect brain health through lifestyle INTErvention to Reduce risk (U.S. POINTER) – Neurovascular Ancillary Study (POINTER-NV) will leverage the rich resources and infrastructure of the parent study U.S. POINTER, an ongoing multi-center randomized clinical trial designed to investigate whether randomization to one of two lifestyle interventions that differ in format and intensity alters cognitive trajectory over 2 years in 2,000 older adults aged 60-79 years. POINTER- NV will comprehensively assess autonomic function, cerebral autoregulation, and vascular structure and function by evaluating aortic, carotid, and cerebral hemodynamics using complementary techniques under a variety of conditions. These neurovascular outcomes will be assessed at baseline, Month 12, and Month 24 in 500 POINTER participants across 5 clinical sites. The primary aim is to assess the effects of the POINTER lifestyle intervention on cerebral autoregulation and baroreflex sensitivity. We will also assess intervention effects on aortic stiffness, carotid stiffness, and cerebral vasomotor reactivity. In addition, POINTER-NV will examine whether these neurovascular outcomes are associated with cognition (assessed every 6 months as part of the parent trial) and brain structure and function (assessed every 1-2 years as part of a Brain Imaging ancillary study). Rationale for Administrative Supplement: The proposed administrative supplement will offset unforeseen costs related to the use of TCD in POINTER-NV. Although discussed in the original application, after confirming details of site-specific equipment available, it has come to our attention that Wake Forest is the only clinical site that has the ability to conduct the type of TCD monitoring needed for the cerebral autoregulation and vasomotor reactivity outcomes. This unforeseen cost was unanticipated and therefore not included in the original grant budget. Thus, the proposed supplement will allow us to purchase the exact equipment needed at the other 4 sites to fully address our aims.

项目概要概述：本申请是为了响应 PA-20-272“行政补充现有 NIH 拨款和合作协议（家长管理支持临床试验可选）”。 R01 AG066910 标题为“POINTER 神经血管辅助研究”的行政补充的内容是确保有适当的经颅多普勒 (TCD) 超声设备和相关用品在所有 5 个参与部位进行评估，以促进大脑自动调节和血管舒缩反应性的评估。参与地点包括维克森林医学院、拉什大学、Advocate Health Care、大学加州大学戴维斯分校（加州大学戴维斯分校）和罗德岛州的背景/意义，具体目标/假设，和方法（包括实验程序、样本量、功效估计和分析计划）尚未自最初申请以来发生了变化（即，没有提出新的科学）。确保可靠且一致的数据收集、加强质量控制并改进数据协调跨站点家长资助摘要：美国通过生活方式保护大脑健康的研究降低风险的干预措施 (U.S. POINTER) – 神经血管辅助研究 (POINTER-NV) 将利用母体研究 U.S. POINTER 的丰富资源和基础设施是一项正在进行的多中心随机旨在调查两种生活方式干预措施中的一种是否随机化的临床试验形式和强度改变了 2,000 名 60-79 岁老年人两年内的认知轨迹。 NV将综合评估自主神经功能、脑自动调节、血管结构等通过使用互补技术评估主动脉、颈动脉和脑血流动力学来评估功能这些神经血管结果将在基线、第 12 个月和第 24 个月进行评估。 5 个临床中心的 500 名 POINTER 参与者主要目的是评估 POINTER 的效果。我们还将评估生活方式对大脑自动调节和压力反射敏感性的干预。此外，POINTER-NV 还会影响主动脉僵硬度、颈动脉僵硬度和脑血管舒缩反应性。检查这些神经血管结果是否与认知相关（每 6 个月评估一次家长试验的一部分）以及大脑结构和功能（每 1-2 年评估一次，作为脑成像的一部分）行政补充的理由：拟议的行政补充将抵消与 POINTER-NV 中使用 TCD 相关的不可预见的成本，尽管在原始版本中已讨论过。应用程序，在确认可用的特定站点设备的详细信息后，我们注意到唤醒森林是唯一有能力进行脑部所需 TCD 监测的临床场所这种不可预见的成本是未预料到的，因此不是。因此，拟议的补充将使我们能够购买确切的补助金。其他 4 个地点需要设备来充分实现我们的目标。