Aiming toWards Evidence baSed inTerpretation of Cardiac biOmarkers in patients pResenting with chest pain-the WESTCOR study: study design

<i>Objectives.</i> The main aim of the Aiming toWards Evidence baSed inTerpretation of Cardiac biOmarkers in patients pResenting with chest pain (WESTCOR-study) (Clinical Trials number NCT02620202) is to improve diagnostic pathways for patients presenting to the Emergency department (ED) with acute chest pain. <i>Design.</i> The WESTCOR-study is a two center, cross-sectional and prospective observational study recruiting unselected patients presenting to the ED with suspected non-ST elevation acute coronary syndrome (NSTE-ACS). Patient inclusion started September 2015 and we plan to include 2250 patients, finishing in 2019. The final diagnosis will be adjudicated by two independent cardiologists based on all available information including serial high sensitivity cardiac troponin measurements, coronary angiography, coronary CT angiography and echocardiography. The study includes one derivation cohort (<i>N</i> = 985) that will be used to develop rule out/rule in algorithms for NSTEMI and NSTE-ACS (if possible) using novel troponin assays, and to validate established NSTEMI algorithms, with and without clinical scoring systems. The study further includes one subcohort (<i>n</i> = 500) where all patients are examined with coronary CT angiography independent of biomarker status, aiming to assess the associations between biomarkers and the extent and severity of coronary atherosclerosis. Finally, an external validation cohort (<i>N</i> = 750) will be included at Stavanger University Hospital. Prospective studies will be based on the merged cohorts. <i>Conclusion.</i> The WESTCOR study will provide new diagnostic algorithms for early inclusion and exclusion of NSTE-ACS and insights in the associations between cardiovascular biomarkers, CT-angiographic findings and short and long-term clinical outcomes.

<i>研究目标。</i> 面向胸痛患者心脏生物标志物循证解读研究（WESTCOR研究，临床试验编号NCT02620202）的核心目标为改善因急性胸痛前往急诊科（Emergency Department, ED）就诊患者的诊疗路径。<i>研究设计。</i> WESTCOR研究为一项双中心、横断面且前瞻性观察性研究，招募因疑似非ST段抬高型急性冠状动脉综合征（non-ST elevation acute coronary syndrome, NSTE-ACS）前往ED就诊的未筛选患者。患者入组始于2015年9月，计划纳入2250例患者，研究将于2019年结束。最终诊断将由2名独立心内科医师基于所有可用信息进行裁定，包括系列高敏心肌肌钙蛋白检测、冠状动脉造影、冠状动脉CT血管造影及超声心动图检查结果。本研究包含一个推导队列（derivation cohort，<i>N</i> = 985），旨在利用新型肌钙蛋白检测方法开发针对非ST段抬高型心肌梗死（non-ST elevation myocardial infarction, NSTEMI）及NSTE-ACS的排除/纳入算法（若可行），并验证带/不带临床评分系统的现有NSTEMI诊断算法。本研究还包含一个亚队列（subcohort，<i>n</i> = 500），所有患者均接受冠状动脉CT血管造影检查，且不受生物标志物检测结果影响，旨在评估生物标志物与冠状动脉粥样硬化的范围及严重程度之间的关联。最后，斯塔万格大学医院（Stavanger University Hospital）将纳入一个外部验证队列（external validation cohort，<i>N</i> = 750）。前瞻性分析将基于合并后的队列开展。<i>研究结论。</i> WESTCOR研究将为NSTE-ACS的早期排除与纳入提供全新的诊断算法，并阐明心血管生物标志物、CT血管造影结果与短期及长期临床结局之间的关联。