Prospective renal insufficiency cohort evaluation: PRICE

项目总结 审评委的研究始于2001年，并于2003年年中招收了第一批参与者。在介入的过程中 多年来，审评委的研究一直达到第一阶段和第三阶段的招聘目标，以及 在研究期间保持对参与者的高水平跟踪。我们已经出版了150多本书 手稿和正在进入第四阶段(2018-2023年)供资的可能性，在此期间，我们 希望跟踪第三阶段(2013-2017；n=1520)新招募的参与者和来自 阶段1(2003-2008年；n=3939)，他们仍活跃在研究中。 我们提出了竞争U01更新中每个临床中心共同的12个具体目标 申请，并提供背景和方法，以纳入和数量的新 将这些测量结果纳入审评委的研究。特别是，我们正在增加创纪录的48项创新措施 心率变异性小时数、加速法体力活动小时数和西风呼吸频率小时数 Biopatch，以及通过ZIO XT Patch进行14天连续心电监测。此外，我们计划 使用当前技术获得对AKI亚临床发作的家庭监测措施 允许用手指测量肌酐，并测量尿蛋白、白蛋白和肌酐 在家中获得并上传到CRIC临床中心。在此应用程序中，我们将重点介绍我们的 中心在CRIC研究中的生产力，特别是将展示非凡的机会 可用于了解心力衰竭，这是CRIC中最常见的单一心血管终点 研究，通过使用这些新技术的生物识别监测，以及我们网站的经验 在这一领域进行了一项试点研究。 在本申请中，我们将回顾CKD的重要方面以及我们临床中心对以下方面的贡献 审评委的努力。此申请包括我们网站(101)的进度报告以及建议书 用于我们机构内外的数据共享和调查人员的招聘 参与评估和发表这项里程碑式的研究成果在《肾脏学》杂志上 社区将推动NIDDK促进肾脏健康的使命并设计 减轻美国成年慢性肾脏病患者慢性肾脏病负担的干预措施。

PROJECT SUMMARY The CRIC Study was initiated in 2001 and enrolled its first participants in mid 2003. In the intervening years the CRIC Study has consistently met recruitment goals in Phase 1 and Phase 3, and maintained a high level of participant follow up during the study. We have published over 150 manuscripts and are entering the potential for a fourth phase (2018-2023) of funding during which we hope to follow up the newly recruited participants from Phase 3 (2013-2017; n=1520) and those from Phase 1 (2003-2008; n=3939) who are still active in the study. We propose 12 Specific Aims that are common to each clinical center in this competing U01 renewal application and provide background and methodology to incorporate and number of new measurements into the CRIC Study. In particular, we are adding innovative measures that record 48 hours of heart rate variability, physical activity by accelerometry and breathing rate via the Zephyr BioPatch, and 14 days of continuous ECG monitoring via the ZIO XT Patch. In addition, we plan obtain measures of in-home monitoring for subclinical episodes of AKI using current technologies that allow a fingerstick creatinine measurement and urine protein, albumin and creatinine measures to be obtained at home and uploaded to the CRIC clinical center. In this application we will focus on our Center's productivity in the CRIC study and in particular will showcase the remarkable opportunity available in the understanding of heart failure, the single most common CV endpoint in the CRIC study, through biometric monitoring using these new technologies, along with our site's experience with a pilot study in this area. In this application we will review important aspects of CKD and contributions of our clinical center to the CRIC effort. This application includes a progress report from our site (101) as well as proposals for data sharing and the recruitment of investigators at our Institution as well as outside our Institution to participate in evaluating and publishing findings from this landmark study in the Nephrologic Community that will further the mission of the NIDDK to promote kidney health and to design interventions that mitigate the burden of CKD in the US adult populations with CKD.