CHRONIC RENAL INSUFFICIENCY COHORT STUDY (CRIC)

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这项研究被称为慢性肾功能不全队列研究（CRIC）。大约有1000万美国人患有慢性肾病（CKD）。CKD患者可能没有任何相关的体征或症状，但有发展为终末期肾衰竭和心血管疾病（CVD）的风险，这两种疾病都有使人衰弱的疾病和过早死亡的高负担。受影响最大的群体是糖尿病患者、高血压患者和非洲人后裔。为什么有些CKD患者会发生不可逆的肾衰竭，或者为什么CVD对CKD患者的影响不成比例，原因尚不清楚。因此，美国国家糖尿病、消化和肾脏疾病研究所（NIDDK）启动了一项队列（观察性）临床研究：(1)确定CKD进展的危险因素；(2)确定/了解心脏病和肾衰竭之间的关系。在这项研究中，来自美国7个主要临床站点的3000名轻度、中度和重度CKD成年患者将被纳入研究。儿童不包括在这项研究中，因为一个平行的努力正在进行研究类似的问题，因为它影响儿童。CRIC的参与者将接受肾功能的精确测量，详细的系列评估，包括病史、饮食习惯和社会心理特征。他们还将接受心血管系统各方面的多项测试（Echo、EKG、EBCT、ABI等），其中一些测试旨在在明显的疾病表现之前识别CVD、CKD及其诱发因素。注册后，参与者将进行一次年度访问和短暂的间隔电话通话，共5至6年。一半的参与者将是糖尿病患者，三分之一将是非洲裔美国人，以反映CKD在这些人群中的优势。CRIC被描述为一项观察性队列研究，因为它不需要进行实验性治疗，也不干预参与者当前或未来的医疗保健。预计该研究结果将成为未来CKD和CVD预防性临床试验的基础。

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 study is called the Chronic Renal Insufficiency Cohort Study (CRIC). About 10 million Americans are afflicted with chronic kidney disease (CKD). The individual with CKD may not have any related signs or symptoms but are at risk of developing end stage renal failure and cardiovascular disease (CVD), both of which carries a high burden of debilitating ill-health and premature death. The most affected groups are patients with diabetes mellitus, hypertension and people of African descent. The reasons why some people with CKD develop irreversible kidney failure or why CVD disproportionately affect people with CKD are not known. Therefore, the National Institutes of Diabetes, Digestive and Kidney Disease (NIDDK) has initiated a cohort (observational) clinical study to: (1) identify the risk factors for progression of CKD and (2) identify/understand the relationship between heart disease and kidney failure. In this study, 3,000 adult patients with mild, moderate and severe CKD will be enrolled from seven major clinical sites across the United States. Children are not included in this study because a parallel effort is underway to study similar issues as it affect children. The participants in CRIC will undergo precise measurement of kidney function, detailed serial assessment including medical history, dietary habit and psychosocial profile. They would also undergo multiple tests of various aspects of the cardiovascular system (Echo, EKG, EBCT, ABI, etc.) Some of these tests are designed to identify CVD, CKD and their precipitating factors before overt ill-heath manifest. After enrolment, participants will undergo one annual visit and a brief interval telephone call for a total of five to six years. Half of the participants will be diabetic and one-third will be African Americans to reflect the preponderance of CKD in these population groups. CRIC is described as an observational cohort study because it does not entail the administration of experimental therapies nor does it intervene with current or future medical care of the participants. It is anticipated that the results of the study would form the basis of preventative clinical trials for both CKD and CVD in the future.