Treat to Target to Reduce Atherosclerosis in Rheumatoid Arthritis

治疗以减少类风湿性关节炎的动脉粥样硬化为目标

• 批准号: 8641657
• 负责人: Joan Marie Bathon
• 金额: $ 35.05万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-01 至 2015-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8641657
• 关键词: Advocate; Affect; Age; Algorithms; Atherosclerosis; Blood Vessels; Cardiovascular Diseases; Cause of Death; Clinical; Clinical Management; Clinical Trials Design; Conflict (Psychology); DNA; Data; Disease; Disease Outcome; Disease-Modifying Second-Line Drugs; Dose; Elderly; Ensure; Epidemiologic Studies; Event; Funding; Gender; General Population; Goals; Grant; Hospitals; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Image; Immunosuppression; Immunosuppressive Agents; Inflammation; Inflammatory; Information Management; Institutional Review Boards; Insulin Resistance; Intervention; Investigation; Joints; Laboratories; Lead; Lipids; Low-Density Lipoproteins; Manuals; Measurement; Measures; Methods; Observational Study; Outcome; Outcome Assessment; Outcome Measure; Pain; Participant; Patients; Pharmaceutical Preparations; Plasma; Procedures; Protocols documentation; Provider; Randomized; Randomized Controlled Trials; Reading; Recruitment Activity; Research Personnel; Rheumatoid Arthritis; Risk; Risk Factors; Safety; Sample Size; Signs and Symptoms; Site; Swelling; TNF gene; Testing; Thick; Time; Training; Translating; Woman; Workplace; arm; base; biobank; cardiovascular disorder risk; design; evidence base; experience; follow-up; improved; interest; intima media; middle age; primary outcome; public health relevance; rheumatologist; secondary outcome; treatment as usual; treatment effect; treatment strategy; trend

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.

描述（由申请人提供）：多项流行病学研究表明，类风湿关节炎（RA）增加心血管疾病（CVD）的风险；它是类风湿性关节炎的头号死因一些观察性研究支持积极免疫抑制对心血管疾病风险的益处，认为RA的炎症负担升高是导致这种风险的原因。然而，关于治疗对心血管疾病风险的影响的观察性研究中存在相互矛盾的发现，重要的是，没有一项研究提供足够的证据基础来告知提供者如何管理这种风险。目前，人们普遍热衷于治疗目标（TTT）治疗关节炎的关节体征和症状。然而，没有数据表明TTT是否可以改善非关节预后，如动脉粥样硬化。该提案描述了一项随机对照试验的基本原理和设计，该试验测试了TTT与常规护理对颈动脉厚度（IMT）进展和其他动脉粥样硬化进展的次要指标的影响。我们要求提供24个月的资金，以进一步规划这项试验。规划期间将包括许多活动，包括选择一个核心血管实验室，确定最佳成像方案，编写成像培训材料，最后确定试验设计和程序，编写操作程序手册，以及地点招聘/选择。我们预计在第2年早期提交试验提案，然后继续进行IRB工作，现场分包，并创建试验材料。这将使我们能够在试验初期就做好招募的准备。该试验将是类风湿性关节炎的首个此类试验，并将为类风湿性关节炎患者心血管风险的管理提供重要的临床信息。