Clinical Center for Prospective Cohort Study of CRI

CRI 前瞻性队列研究临床中心

• 批准号: 8312721
• 负责人: Jiang He
• 金额: $ 67.25万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 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 2013-08-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8312721
• 关键词: Address; Adult; Adverse event; Ancillary Study; Anemia; Area; Biological; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Chronic; Chronic Kidney Failure; Chronic Kidney Insufficiency; Clinical; Cohort Studies; Collaborations; Collection; Communities; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Quality; Development; Documentation; Early treatment; Eligibility Determination; End stage renal failure; Enrollment; Etiology; Event; Excretory function; Filtration; Gender; Glomerular Filtration Rate; Health Sciences; Hurricane; Incidence; Intervention Studies; Kidney; Kidney Diseases; Laboratories; Malnutrition; Manuals; Manuscripts; Measurement; Measures; Medical; Medical Records; Monitor; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Nephrology; Outcome; Participant; Patient Self-Report; Patients; Phase; Preparation; Procedures; Prognostic Factor; Proteins; Protocols documentation; Public Health; Publishing; Quality Control; Race; Reading; Recording of previous events; Recruitment Activity; Renal function; Research; Research Personnel; Resources; Risk Factors; Science; Shipping; Ships; Specimen; Subgroup; Testing; Training; United States; Universities; base; burden of illness; cohort; computerized data processing; disease natural history; disorder risk; follow-up; health related quality of life; insight; instrument; meetings; mortality; novel; operation; premature; prospective; quality assurance; secondary outcome; success; urinary; Address; Adult; Adverse event; Ancillary Study; Anemia; Area; Biological; Cardiovascular Diseases; Cardiovascular system; Cessation of life; Chronic; Chronic Kidney Failure; Chronic Kidney Insufficiency; Clinical; Cohort Studies; Collaborations; Collection; Communities; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Quality; Development; Documentation; Early treatment; Eligibility Determination; End stage renal failure; Enrollment; Etiology; Event; Excretory function; Filtration; Gender; Glomerular Filtration Rate; Health Sciences; Hurricane; Incidence; Intervention Studies; Kidney; Kidney Diseases; Laboratories; Malnutrition; Manuals; Manuscripts; Measurement; Measures; Medical; Medical Records; Monitor; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Nephrology; Outcome; Participant; Patient Self-Report; Patients; Phase; Preparation; Procedures; Prognostic Factor; Proteins; Protocols documentation; Public Health; Publishing; Quality Control; Race; Reading; Recording of previous events; Recruitment Activity; Renal function; Research; Research Personnel; Resources; Risk Factors; Science; Shipping; Ships; Specimen; Subgroup; Testing; Training; United States; Universities; base; burden of illness; cohort; computerized data processing; disease natural history; disorder risk; follow-up; health related quality of life; insight; instrument; meetings; mortality; novel; operation; premature; prospective; quality assurance; secondary outcome; success; urinary

DESCRIPTION (provided by applicant): Chronic kidney disease (CKD) has become an important public health challenge in the United States. CKD is a major risk factor for end-stage renal disease (ESRD), cardiovascular disease (CVD), and premature death. Understanding novel risk factors for the progression of CKD and associated CVD may help to develop effective approaches for early intervention in order to reduce the adverse disease burden. The Chronic Renal Insufficiency Cohort (CRIC) Study is a NIDDK-sponsored multi-center prospective cohort study. The overall objective of the CRIC study is to investigate novel risk factors for the progression of CKD and development of CVD among patients with chronic renal insufficiency. The CRIC study has recruited 3,612 adult patients with CKD from 7 clinical centers in the US. The study participants are followed for renal and cardiovascular outcomes up to 5 years in the initial phase (CRIC phase-1). The CRIC Tulane Clinical Center recruited 405 study participants and achieved a respective follow-up rate despite devastation caused by hurricane Katrina in the New Orleans area. The proposed CRIC phase-2 which extends follow-up through 2013, offers a unique opportunity to leverage the existing effort and success of CRIC to establish a cohort of CKD participants who have long-term prospective follow-up on progression of kidney disease and a variety of different outcomes. This unparalleled resource will also expand the science related to CKD natural history as well as the impact on CVD and other adverse events. Specific aims to be addressed by the Tulane Clinical Center are: (1). to re-enroll a high percentage of CRIC phase-1 participants into phase-2; (2). to collect exposure and outcome data per the CRIC phase 1 and 2 protocols; (3). to maintain high levels of retention in the study; (4). to investigate self-reported clinical events and obtain supporting medical records and documentation; (5). to enter data and process/ship biological specimens; (6). to implement local quality assurance and quality control procedures as a means to obtain standardized, high quality measurements; (7). to monitor data collection, data entry, and follow-up rates; (8). to participate in governance and oversight of the CRIC study through study-wide subcommittees and activities; (9). to publish and present findings from the CRIC Study; and (10). to promote and support the conduct of ancillary studies in CRIC, including collaboration with the broader nephrology research community. The proposed study may provide insights into the underlying etiology of progression of CKD and related CVD and information for developing further intervention studies aimed at reducing morbidity and mortality of ESRD and CVD among patients with CKD.

描述（由申请人提供）： 慢性肾脏疾病（CKD）已成为美国重要的公共卫生挑战。 CKD是终末期肾脏疾病（ESRD），心血管疾病（CVD）和过早死亡的主要危险因素。了解CKD和相关CVD进展的新型风险因素可能有助于开发有效的早期干预方法，以减轻不良疾病负担。 慢性肾功能不全队列（CRIC）研究是NIDDK赞助的多中心前瞻性队列研究。 CRIC研究的总体目的是研究CKD进展的新风险因素和CVD的发展，患有慢性肾功能不全的患者。这项CRIC研究已从美国7个临床中心招募了3,612例CKD患者。在初始阶段（CRIC阶段1），遵循研究参与者的肾脏和心血管结局长达5年。 Cric Tulane临床中心招募了405名研究参与者，并达到了各自的随访率，尽管卡特里娜飓风在新奥尔良地区造成了破坏。 拟议的CRIC 2阶段将延伸到2013年的后续行动，提供了一个独特的机会，可以利用CRIC的现有努力和成功建立一群CKD参与者，这些参与者对肾脏疾病进展的长期前瞻性随访以及各种不同的结果。这种无与伦比的资源还将扩大与CKD自然历史有关的科学，以及对CVD和其他不良事件的影响。图兰临床中心要解决的具体目标是：（1）。将很高比例的CRIC 1阶段参与者重新注册为2阶段； （2）。根据CRIC 1和2协议收集暴露和结果数据； （3）。在研究中保持高水平的保留； （4）。调查自我报告的临床事件并获得支持的医疗记录和文件； （5）。输入数据和过程/船舶生物标本； （6）。实施本地质量保证和质量控制程序，以获取标准化的高质量测量； （7）。监视数据收集，数据输入和随访率； （8）。通过研究范围的小组委员会和活动参与CRIC研究的治理和监督； （9）。发表并介绍CRIC研究的发现； （10）。为了促进和支持CRIC的辅助研究的进行，包括与更广泛的肾脏病研究界的合作。 拟议的研究可能会提供有关CKD和相关CVD进展的潜在病因，以及开发旨在降低CKD患者ESRD和CVD的发病率和死亡率的进一步干预研究的信息。