CHRONIC RENAL INSUFFICIENCY COHORT (CRIC) STUDY

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。这是一项多中心观察性研究，旨在了解进行性肾脏疾病与心血管疾病之间的关系。该研究的主要目的是检查不同严重程度的慢性肾功能不全（CRI）和心血管疾病（CVD）事件的风险因素，并开发预测模型，以识别CRI的高风险亚组。后者的结果将针对未来治疗试验招募高风险受试者，并增加可用预防疗法的应用。提高对病因因素的认识将允许开发和测试干预措施，以减少晚期肾衰竭和心血管发病率和死亡率的负担。本研究将探讨以下假设：1）一组非传统风险因素与CRI进展和终末期肾病的发生相关，2）一组非传统风险因素与CRI背景下的CVD事件和CVD进展指标相关，3）CRI背景下CRI进展和CVD的风险因素因人口统计学特征而异（年龄/性别，种族/民族）和糖尿病状态，4）与CRI及其进展相关的发病率和并发症降低总体和疾病特异性生活质量，损害功能状态，并增加健康资源利用，和5）CRI的进展，如通过血清肌酐，1/血清肌酐，目前可用的基于血清肌酐的公式可能会对CRI的进展速率产生有偏差的估计。CRIC研究人群将包括一组具有种族和人种多样性的轻度至中度慢性肾功能不全成人患者（年龄21-74岁）（估计半数受试者将诊断为糖尿病）。将在全国7家临床试验机构招募3000名受试者，在该临床试验机构招募450-500名受试者。将在整个临床随访期间（6年）或直至死亡对队列成员进行随访。本研究包括筛选和基线访视、年度门诊访视和门诊访视之间的电话访谈。将收集广泛的数据，包括：1）社会人口统计学、合并症、治疗、人体测量学、心理社会学、生活质量和医疗保健资源利用指标，2）肾功能指标，3）心血管指标和4）生化指标。约三分之一的受试者（随机选择）将在基线、2年和4年访视时进行肾小球滤过率（GFR）检测。本研究将要求每例受试者在GCRC进行7次门诊访视。

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