Carotid Intima-Media Thickness in Chronic Kidney Disease: a CRIC ancillary study

描述（由申请方提供）：心血管疾病在慢性肾脏疾病（CKD）患者中很常见。CKD患者更可能发生心血管事件（心肌梗死、中风、心力衰竭和猝死），而不是进展为需要透析或移植的终末期肾病。传统的风险因素，如血脂异常、糖尿病、吸烟和高血压，在这一人群中非常普遍，并有助于CKD的进展，但在这些患者中是心血管事件的有限预测因素。在风险预测评分中使用传统的风险因素，如Fragrance风险评分，会导致对心血管疾病（CVD）风险的估计不足。最近的研究表明，新的心血管危险因素，如氧化应激和慢性炎症是CKD透析患者心血管疾病的独立危险因素。我们正在回应项目公告PAR-07-024，标题为“主要正在进行的NIDDK和NHLBI临床研究的辅助研究”。NIDDK慢性肾功能不全队列（CRIC）研究于2003年启动，旨在确定轻度至重度慢性肾病成人中心血管疾病和肾病进展的风险因素;随访将持续到2013年6月。该队列研究提供了一个前所未有的机会来研究氧化应激和慢性炎症在CVD的存在和进展中的作用，通过颈动脉内膜中层厚度（IMT）进行测量。通过超声测量颈动脉IMT评估动脉粥样硬化的范围和严重程度。425名CRIC受试者的初步数据表明IMT与传统和非传统心血管危险因素相关。拟定的前瞻性研究将在2个不同的CRIC研究中心增加另外400例受试者的IMT测量，允许评价上述425例受试者的IMT进展，并确定颈动脉IMT是否可预测CKD患者的心血管事件。氧化应激和炎症标志物的测定将在与颈动脉IMT评价相同的时间点进行。这项研究的目的是：确定轻度至重度CKD患者颈动脉IMT增加的患病率和风险因素，确定轻度至重度CKD患者颈动脉IMT进展的风险因素，并确定IMT是否是CKD患者心血管事件的预测因子。新的心血管风险因素可能导致CKD患者心血管并发症的严重负担。阐明心血管疾病和新的危险因素之间的关系是预测心血管疾病风险的重要组成部分，并确定可改变的心血管疾病进展的危险因素，这可能有助于开发预期的随机临床试验，以减少疾病进展。

DESCRIPTION (provided by applicant): Cardiovascular disease is common in chronic kidney disease (CKD) patients. CKD patients are more likely to have a cardiovascular event (myocardial infarction, stroke, heart failure and sudden death) than to progress to end-stage renal disease requiring dialysis or transplantation. Traditional risk factors, such as dyslipidemia, diabetes, smoking and hypertension, are very prevalent in this population, and contribute to the progression of CKD, but are limited predictors of cardiovascular events in these patients. Use of traditional risk factors in risk prediction scores such as the Framingham risk score results in under estimation of cardiovascular disease (CVD) risk. Recent studies have shown that novel cardiovascular risk factors such as oxidative stress and chronic inflammation are independent risk factors for cardiovascular disease in CKD patients on dialysis. We are responding to program announcement PAR-07-024, titled "Ancillary Studies to Major Ongoing NIDDK and NHLBI Clinical Research Studies". The NIDDK Chronic Renal Insufficiency Cohort (CRIC) study was initiated in 2003 to identify risk factors for CVD and progression of renal disease in adults with mild to severe CKD; follow-up visits will extend through June 2013. This cohort provides an unprecedented opportunity to investigate the role of oxidative stress and chronic inflammation in the presence and progression of CVD as measured by carotid intima-media thickness (IMT). Carotid IMT measured by ultrasound assesses the extent and severity of atherosclerosis. Preliminary data in 425 CRIC subjects demonstrate an association of IMT with traditional and non-traditional cardiovascular risk factors. The proposed prospective study will add IMT measurements in an additional 400 subjects at 2 different CRIC sites, allow for evaluation of progression of IMT in the above 425 subjects and determine if carotid IMT predicts cardiovascular events in CKD patients. Assays for oxidative stress and inflammatory markers will be measured at the same time points as the carotid IMT evaluation. he aims of the study are: to determine the prevalence and risk factors for increased carotid IMT in mild to severe CKD, to determine risk factors for progression of carotid IMT in mild to severe CKD and to determine if IMT is a predictor for cardiovascular events in CKD patients. Novel cardiovascular risk factors likely contribute to the substantial burden of cardiovascular complications in patients with CKD. Elucidation of the relationship between CVD and novel risk factors is an essential component for the prediction of cardiovascular risk and to identify modifiable risk factors for the progression of CVD that could aid in the development of anticipated randomized clinical trials to decrease disease progression.