Treat to Target to Reduce Atherosclerosis in Rheumatoid Arthritis

描述（由申请人提供）：多项流行病学研究表明，类风湿性关节炎（RA）患者心血管疾病（CVD）的风险增加; CVD是RA患者的头号死因。RA的炎症负荷升高被认为是导致这种风险的原因，许多观察性研究支持积极的免疫抑制对CVD风险的益处。然而，关于治疗对CVD风险的影响的观察性研究中存在相互矛盾的结果，重要的是，没有一项研究提供了足够的证据基础来告知提供者如何管理这种风险。目前，有普遍的热情治疗目标（TTT）在类风湿关节炎管理关节的体征和症状。然而，没有数据表明TTT是否可以改善非关节结局，如动脉粥样硬化。 该提案描述了一项随机对照试验的原理和设计，该试验测试TTT与常规护理对颈动脉厚度（IMT）进展和动脉粥样硬化进展的其他次要指标的影响。我们要求24个月的资金，以进一步计划这项试验。规划期间将开展许多活动，包括选择核心血管实验室、确定最佳成像方案、编制成像培训材料、最终确定试验设计和程序、编制操作程序手册以及招募/选择研究中心。我们预计在第2年早期提交试验提案，然后继续IRB工作、研究中心分包和创建试验材料。这将使我们能够在试用期的早期就做好招聘准备。 该试验将是首个此类RA试验，并将为RA患者CV风险的管理提供重要的临床信息。

DESCRIPTION (provided by applicant): Multiple epidemiologic studies have demonstrated an increased risk of cardiovascular disease (CVD) in rheumatoid arthritis (RA); it is the number one cause of death in RA. The elevated inflammatory burden of RA is postulated to contribute to this risk, supported by a number of observational studies supporting the benefits of aggressive immunosuppression on CVD risk. However, there are conflicting findings among the observational studies regarding the effect of treatment on CVD risk, and, importantly, none provides a sufficient evidence-base to inform providers how to manage this risk. Currently, there is general enthusiasm regarding Treat to Target (TTT) in RA for managing articular signs and symptoms. However, there are no data whether TTT may improve non-articular outcomes, such as atherosclerosis. This proposal describes the rationale and design of a randomized controlled trial testing the effects of TTT versus usual care on the progression of carotid thickness (IMT) and other secondary measures of atherosclerosis progression. We request 24 months of funding to further plan this trial. The planning period will entail many activities, including selecting a core vascular laboratory, determining the best imaging protocol, developing training materials for the imaging, finalizing trial design and procedures, developing a Manual of Operating Procedures, and site recruitment/selection. We anticipate submission of a trial proposal early during year 2 and then continuing with IRB work, site subcontracting, and creating trial materials. This will allow us to be ready to recruit early in the trial period. Thetrial will be the first of its kind in RA and will provide important clinical information for the management of CV risk in RA patients.