Prospective renal insufficiency cohort evaluation: PRICE

前瞻性肾功能不全队列评估：PRICE

• 批准号: 10466834
• 负责人: DEBBIE L COHEN
• 金额: $ 68.93万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-28 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10466834
• 关键词: Accelerometer; Acute; Address; Adult; Albumins; Ambulatory Blood Pressure Monitoring; Ancillary Study; Apple watch; Area; Bioinformatics; Biological; Biological Markers; Biometry; Breathing; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Chronic Kidney Failure; Chronic Kidney Insufficiency; Clinical; Cohort Studies; Collaborations; Communities; Complex; Creatinine; Data; Data Coordinating Center; Development; Devices; Disease Progression; Documentation; Electrocardiogram; Enrollment; Ensure; Evaluation; Event; Feasibility Studies; Fibroblast Growth Factor; Funding; Goals; Grant; Health; Heart Diseases; Heart failure; Home; Hour; Impairment; Individual; Institution; Kidney; Kidney Diseases; Kidney Failure; Learning; Letters; Manuscripts; Measurement; Measures; Medical Genetics; Medical Records; Methodology; Methods; Mission; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Older Population; Outcome; Paper; Parents; Participant; Patient Recruitments; Patient Self-Report; Pennsylvania; Persons; Phase; Phenotype; Philadelphia; Physical activity; Pilot Projects; Population; Procedures; Productivity; Progress Reports; Proteins; Proteinuria; Protocols documentation; Publishing; Quality Control; Questionnaires; Renal function; Research; Research Personnel; Resources; Risk; Risk Factors; Role; Schedule; Science; Site; Specimen; Standardization; Technology; Universities; Urine; Variant; Writing; base; clinical center; cohort; data sharing; design; experience; fitbit; follow-up; heart rate variability; human subject; innovation; kidney dysfunction; longitudinal dataset; meetings; member; new technology; novel; participant retention; phenotypic data; programs; prospective; quality assurance; recruit; response; therapy design

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.

项目概要 CRIC 研究于 2001 年启动，并于 2003 年中期招募了第一批参与者。 多年来，CRIC 研究一直达到第一阶段和第三阶段的招募目标，并且 在研究期间保持高水平的参与者随访。我们已经出版了 150 多个 手稿并正在进入第四阶段（2018-2023）资助的潜力，在此期间我们 希望对第三阶段（2013-2017；n=1520）新招募的参与者以及来自 第 1 阶段（2003-2008 年；n=3939）仍在积极参与该研究的人。 我们在 U01 更新竞争中提出了每个临床中心共同的 12 个具体目标 应用程序并提供合并的背景和方法以及新的数量 测量纳入 CRIC 研究。特别是，我们正在增加创新措施，记录了 48 心率变化小时数、通过加速度测量的体力活动以及通过 Zephyr 的呼吸频率 BioPatch，以及通过 ZIO XT 补丁进行 14 天的连续心电图监测。此外，我们还计划 使用当前技术获得 AKI 亚临床发作的家庭监测措施 允许进行指尖血肌酐测量以及尿蛋白、白蛋白和肌酐测量 在家获取并上传至 CRIC 临床中心。在此应用程序中，我们将重点关注我们的 中心在 CRIC 研究中的生产力，尤其将展示非凡的机会 可用于了解心力衰竭，这是 CRIC 中最常见的单一心血管终点 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进行研究 并在该领域进行了试点研究。 在此申请中，我们将回顾 CKD 的重要方面以及我们的临床中心对 审评委的努力。该申请包括我们网站 (101) 的进度报告以及提案 用于我们机构内外的数据共享和调查人员的招募 参与《肾病学》杂志上这项具有里程碑意义的研究的评估和发表结果 社区将进一步推进 NIDDK 促进肾脏健康和设计的使命 减轻美国 CKD 成人人群的 CKD 负担的干预措施。