SPRINT - Factors Affecting Atherosclerosis Study (FAST)

SPRINT - 影响动脉粥样硬化的因素研究 (FAST)

• 批准号: 8313947
• 负责人: SRINIVASAN BEDDHU
• 金额: $ 59.87万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-05 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8313947
• 关键词: Address; Adult; Affect; Alkaline Phosphatase; Ancillary Study; Arterial Fatty Streak; Atherosclerosis; Biological Assay; Blood; Blood Pressure; Calcium; Cardiovascular system; Carotid Arteries; Central obesity; Cessation of life; Chronic Kidney Failure; Clinic; Colorado; Enrollment; Event; Future; General Population; Goals; Image; Incidence; Intervention; Intervention Trial; Kidney Diseases; Lead; Magnetic Resonance Imaging; Measures; Mediating; Metabolism; Minerals; Minnesota; Modification; Names; Obesity; Outcome; Parents; Participant; Patients; Phosphorus; Plasma; Play; Population; Population Study; Prevalence; Process; Protocols documentation; Public Health; Reading; Recruitment Activity; Relative (related person); Resources; Risk Factors; Role; Sampling; Serum; Site; Specific qualifier value; Systolic Pressure; Testing; United States National Institutes of Health; Universities; Urine; Utah; Vitamin D; Vitamin D2; Washington; abdominal fat; aged; blood pressure regulation; bone; calcification; cardiovascular risk factor; design; fibroblast growth factor 23; forest; high risk; improved; insight; non-diabetic; randomized trial; secondary outcome; waist circumference

DESCRIPTION (provided by applicant): There is a substantially higher incidence of cardiovascular events and cardiovascular deaths in the chronic kidney disease (CKD) population compared to the general population. However, there are several unresolved questions regarding the mechanisms that lead to increased cardiovascular events in the CKD population. It remains unclear 1. whether CKD by itself leads to accelerated atherosclerosis and 2. What the relative contribution of traditional and non-traditional risk factors to progression of atherosclerosis in CKD are. As the Systolic Pressure Intervention Trial (SPRINT) has a unique design of enrolling a large number of CKD and non-CKD participants at high risk for atherosclerotic events, this trial provides a great opportunity to examine whether atherosclerosis progression is accelerated in CKD compared to non-CKD and the factors that contribute to the greater prevalence of atherosclerosis in CKD. Therefore, in this ancillary study to SPRINT, we propose to examine (1) Whether there is a faster rate of progression of atherosclerosis in CKD compared to the non-CKD population and (2) Whether abdominal obesity and factors reflective of abnormal bone and mineral metabolism (plasma calcium, phosphorus, alkaline phosphatase, 25 and 1,25 vitamin D and fibroblast growth factor 23 levels) play a significant role in progression of atherosclerosis or calcification of atheromatous plaques in the CKD population. SPRINT, a large scale randomized trial of ~ 9250 adults aged 55 years or older with high cardiovascular risk will test the effects of low SBP goal of < 120 mm Hg vs. the standard goal of < 140 mm Hg on the primary composite of cardiovascular events and death. SPRINT is expected to start enrolling patients in Oct, 2010. SPRINT will recruit 45% of the study population with CKD. For this ancillary study, 480 SPRINT participants (240 with CKD and 240 without) will be recruited in 6 SPRINT sites. These sites include the University of Utah, Stanford University, University of Colorado at Denver, Case Western Reserve University, Cleveland Clinic and the University of Pittsburgh. Following standardized protocols, participants will undergo carotid MRI to measure atherosclerosis at baseline and 30 months. These images will be read by the Carotid MRI Reading Center at the University of Washington. Blood and urine samples will be carefully collected, processed and stored at baseline, 12 and 30 months. Assays will be performed at University of Minnesota and the University of Utah. Statistical analyses will be conducted at the SPRINT Coordinating Center at the Wake Forest University. We believe the strengths (the unique opportunity to examine a large number of CKD and non-CKD participants, the importance of the questions to be examined, the strength of the investigative team and the availability of resources) of this proposal will lead to successful conclusion of the ancillary study and the results will guide designing future RCTs targeting atherosclerosis in CKD.

描述（由申请方提供）：与一般人群相比，慢性肾脏病（CKD）人群中心血管事件和心血管死亡的发生率显著较高。然而，关于导致CKD人群心血管事件增加的机制，仍有一些未解决的问题。目前尚不清楚1。CKD本身是否导致动脉粥样硬化加速; 2.传统和非传统危险因素对CKD患者动脉粥样硬化进展的相对影响。 由于收缩压干预试验（SPRINT）具有招募大量动脉粥样硬化事件高风险的CKD和非CKD受试者的独特设计，因此该试验提供了一个很好的机会来检查CKD患者的动脉粥样硬化进展是否比非CKD患者加速，以及导致CKD患者动脉粥样硬化患病率更高的因素。 因此，在这项SPRINT的辅助研究中，我们建议检查（1）与非CKD人群相比，CKD患者动脉粥样硬化的进展速度是否更快，以及（2）腹部肥胖和反映骨和矿物质代谢异常的因素是否与CKD患者的动脉粥样硬化进展速度有关。（血浆钙、磷、碱性磷酸酶，25和1，维生素D和成纤维细胞生长因子23水平）在CKD人群中动脉粥样硬化或动脉粥样硬化斑块钙化的进展中起重要作用。 SPRINT是一项在约9250名年龄在55岁或以上的心血管高风险成人中进行的大规模随机试验，将测试< 120 mm Hg的低SBP目标与< 140 mm Hg的标准目标对心血管事件和死亡的主要复合终点的影响。预计SPRINT将于2010年10月开始招募患者。SPRINT将招募45%的CKD研究人群。对于这项辅助研究，将在6个SPRINT研究中心招募480名SPRINT受试者（240名CKD受试者和240名非CKD受试者）。这些地点包括犹他州大学、斯坦福大学、丹佛的科罗拉多大学、凯斯西储大学、克利夫兰诊所和匹兹堡大学。按照标准化方案，参与者将接受颈动脉MRI，以测量基线和30个月时的动脉粥样硬化。这些图像将由华盛顿大学颈动脉MRI阅读中心读取。将在基线、12个月和30个月时仔细采集、处理和储存血液和尿液样本。试验将在明尼苏达大学和犹他州大学进行。统计分析将在维克森林大学的SPRINT协调中心进行。 我们相信，该提案的优势（检查大量CKD和非CKD受试者的独特机会、待检查问题的重要性、研究团队的优势和资源的可用性）将导致辅助研究的成功结束，并且结果将指导设计未来针对CKD动脉粥样硬化的RCT。