CRIC STUDY

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。在过去的几十年里，终末期肾病(ESRD)在美国和其他国家的发病率和患病率稳步上升。对慢性肾功能不全(CRI)的流行病学了解相对较少，CRI是终末期肾病(ESRD)之前肾功能下降的阶段。CRI影响着1000多万美国人。CRI的发病率和死亡率负担源于CRI向终末期肾病的频繁但可变的进展以及CRI环境下心血管疾病(CVD)的不成比例风险。2001年，国家糖尿病、消化和肾脏疾病研究所(NIDDK)建立了慢性肾功能不全队列(CRIC)研究。CRIC的主要目标是在CRI的背景下确定CRI进展的风险因素和CVD的风险因素。预计CRIC的结果将为未来的治疗提供科学基础，将促进后续临床试验的设计，并最终将导致预防终末期肾病及其并发症。霍普金斯大学(与马里兰州大学签订了分包合同)是将招收约430-500名CRI患者以建立3000名受试者(约50%糖尿病)的七个临床中心之一。该研究预计，将有约6,000人(约1,000人/中心)进行面对面筛查，以达到队列样本量。参与者被跟踪，直到死亡或退出研究。根据招生日期的不同，随访期为3至6年。在每年的后续行动中，每年都会进行面对面的访问以及1-2次电话联系。在年度访问中，将收集以下数据：空腹血样、24小时尿样、问卷(人口统计学、饮食、合并疾病、生活质量、医疗保健利用率、并发医疗事件)、EKG、生物电阻抗和踝臂指数。每隔一年，将进行一次超声心动图检查。三分之一的CRIC参与者(全研究范围内1000人，每个中心约150人)将成为接受额外研究程序(GFR和EBT)的‘次队列’或‘次研究’的一部分。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Over the past several decades, the incidence and prevalence of end-stage renal disease (ESRD) has increased steadily in the United States and other countries. Relatively little is known about the epidemiology of chronic renal insufficiency (CRI), the stage of reduced kidney function prior to ESRD. CRI affects more than 10 million Americans. The burden of morbidity and mortality from CRI derives from the frequent but variable progression of CRI toward ESRD and the disproportionate risk of cardiovascular disease (CVD) in the setting of CRI. In 2001, the National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) established the Chronic Renal Insufficiency Cohort (CRIC) Study. The main goals of CRIC are to determine risk factors for CRI progression and risk factors for CVD in the setting of CRI. It is anticipated that results from CRIC will provide the scientific foundation for future treatments, will facilitate the design of subsequent clinical trials, and will ulitmately lead to the prevention of ESRD and its complications. Hopkins (with a subcontract to U.Maryland) is one of seven clinical centers that will enroll approximately 430-500 individuals with CRI to establish a cohort of 3,000 subjects (~50% diabetic). The study anticipates that ~6,000 individuals studywide (~1,000/center) will be screened in-person to achieve the cohort sample size. Participants are followed until death or dropout from the study. The duration of follow-up will be 3 to 6 years, depending on the date of enrollment. Each year during follow-up, annual in-person visits will occur as well as 1-2 telephone contacts. At the annual visits, the following data will be collected: fasting blood specimen, 24 hour urine collection, questionnaires (demographics, diet, co-morbid medical conditions, quality of life, health care utlilization, intercurrent medical events), EKG, bioelectrical impedance, and ankle-brachial index. Every other year, an echocardiogram will be performed. One third of CRIC participants (1,000 studywide, ~150 per center) will be part of the 'subcohort' or 'substudy' that receives additional study procedures (GFR and EBT).