CHRONIC RENAL INSUFFICIENCY COHORT (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。这是一项多中心观察性研究，旨在了解进行性肾脏疾病和心血管疾病之间的关系。这项研究的主要目标是检查慢性肾功能不全(CRI)和心血管疾病(CVD)事件的危险因素，并开发预测模型，以确定CRI的高危亚组。后一项结果将把高危受试者纳入未来的治疗试验，并增加现有预防疗法的应用。对病因认识的提高将使干预措施的开发和测试成为可能，以减少晚期肾功能衰竭以及心血管发病率和死亡率的负担。这项研究将解决以下假设：1)一组非传统危险因素与CRI的进展和终末期肾脏疾病的发展有关，2)一组非传统危险因素与CRI环境中的CVD事件和CVD进展的测量有关，3)CRI环境中CRI进展和CVD的危险因素因人口特征(年龄/性别、种族/民族)和糖尿病状况而不同，4)与CRI及其进展相关的发病率和并发症降低全球和疾病特有的生活质量，损害功能状态，并增加卫生资源的利用，5)用血清肌酐、1/血清肌酐和目前可用的基于血肌酐的公式估计CRI的进展可能会对CRI的进展速度产生偏见的估计。CRIC的研究人群将包括一组不同种族和民族的成人患者(年龄21-74岁)，他们患有轻到中度的慢性肾功能不全(据估计，一半的受试者将被诊断为糖尿病)。3,000名参与者将在全国7个中心招收，450-500名受试者在这个网站。队列成员将在整个临床随访期间(6年)或直至死亡。这项研究包括筛查和基线访问、年度诊所访问以及在两次诊所访问之间进行的电话采访。将收集广泛的数据，包括：1)社会人口学、共病、治疗、人体测量、心理社会、生活质量和卫生保健资源利用指标，2)肾功能指标，3)心血管指标，4)生化指标。大约三分之一的受试者(随机选择)将在基线、2年和4年就诊时进行肾小球滤过率(GFR)测试。这项研究将要求每个子项目在GCRC门诊就诊7次

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. This is a multicenter observational study to gain understanding of the relationship between progressive renal disease and cardiovascular illness. The principal goals of the study are to examine risk factors for chronic renal insufficiency (CRI) and cardiovascular disease (CVD) events among patients with varying severity of CRI, and to develop predictive models that will identify high-risk subgroups with CRI. The latter results will target enrollment of high-risk subjects into future treatment trials and increase application of available preventive therapies. Improved recognition of etiological factors will permit development and testing of interventions to reduce the burden of advanced renal failure and cardiovascular morbidity and mortality. The study will address the following hypotheses: 1) A set of non-traditional risk factors is associated with both progression of CRI and development of end stage renal disease, 2) A set of non-traditional risk factors is associated with CVD events and measures of CVD progression in the setting of CRI, 3) The risk factors for CRI progression and CVD in the setting of CRI vary by demographic characteristics (age/gender, race/ethnicity) and diabetes status, 4) The morbidity and complications associated with CRI and its progression diminish global and disease-specific quality of life, impair functional status, and increase health resource utilization, and 5) Progression of CRI as estimated by serum creatinine, 1/serum creatinine, and currently available serum creatinine-based formulae may yield biased estimates of the rate of progression of CRI. The CRIC study population will include a racially and ethnically diverse group of adult patients (age 21-74) with mild-to-moderate chronic renal insufficiency (it is estimated that half of the subjects will have diagnosed diabetes mellitus). 3000 participants will be enrolled nationally at 7 centers, 450-500 subjects at this site. Cohort members will be followed throughout the entire duration of clinical follow-up (6 years) or until death. The study consists of screening and baseline visits, annual clinic visits, and telephone interviews in between clinic visits. Extensive data will be collected including: 1) sociodemographic, comorbidity, treatment, anthropometric, psychosocial, quality of life and health care resource utilization measures, 2) renal function measures, 3) cardiovascular measures, and 4) biochemical measures. Approximately one third of the subjects (randomly selected) will have glomerular filtration rate (GFR) testing at the baseline, 2-year and 4-year visits. This study will require 7 outpatient visits at the GCRC per subjec