Background The optimal noninvasive method for surveillance in symptomatic patients with stable coronary artery disease (CAD) is unknown. Objective To apply a novel approach using very low concentrations of high-sensitivity cardiac troponin I (hs-cTnI) for exclusion of inducible myocardial ischemia in symptomatic patients with CAD. Design Prospective diagnostic cohort study. (ClinicalTrials.gov: NCT01838148). Setting University hospital. Patients 1896 consecutive patients with CAD referred with symptoms possibly related to inducible myocardial ischemia. Measurements Presence of inducible myocardial ischemia was adjudicated using myocardial perfusion imaging with single-photon emission computed tomography, as well as coronary angiography and fractional flow reserve measurements where available. Staff blinded to adjudication measured circulating hs-cTn concentrations. An hs-cTnI cutoff of 2.5 ng/L, derived previously in mostly asymptomatic patients with CAD, was assessed. Predefined target performance criteria were at least 90% negative predictive value (NPV) and at least 90% sensitivity for exclusion of inducible myocardial ischemia. Sensitivity analyses were based on measurements with an hs-cTnT assay and an alternative hs-cTnI assay with even higher analytic sensitivity (limit of detection, 0.1 ng/L). Results Overall, 865 patients (46%) had inducible myocardial ischemia. The hs-cTnI cutoff of 2.5 ng/L provided an NPV of 70% (95% CI, 64% to 75%) and a sensitivity of 90% (CI, 88% to 92%) for exclusion of inducible myocardial ischemia. No hs-cTnI cutoff reached both performance characteristics predefined as targets. Similarly, using the alternative assays for hs-cTnI or hs-cTnT, no cutoff achieved the target performance: hs-cTnT concentrations less than 5 ng/L yielded an NPV of 66% (CI, 59% to 72%), and hs-cTnI concentrations less than 2 ng/L yielded an NPV of 68% (CI, 62% to 74%). Limitation Data were generated in a large single-center diagnostic study using central adjudication. Conclusion In symptomatic patients with CAD, very low hs-cTn concentrations, including hs-cTnI concentrations less than 2.5 ng/L, do not generally allow users to safely exclude inducible myocardial ischemia. Primary Funding Source European Union, Swiss National Science Foundation, Kommission für Technologie und Innovation (Innosuisse), Swiss Heart Foundation, Cardiovascular Research Foundation Basel, University of Basel, University Hospital Basel, Roche, Abbott, and Singulex.

中文翻译：

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使用高敏感性心肌肌钙蛋白排除有症状患者的诱导型心肌缺血：一项队列研究。

背景技术稳定冠状动脉疾病（CAD）症状患者的最佳无创监视方法尚不清楚。目的应用一种应用低浓度高敏感性心肌肌钙蛋白I（hs-cTnI）的新方法排除有症状的CAD患者的可诱导性心肌缺血。设计前瞻性诊断队列研究。（ClinicalTrials.gov：NCT01838148）。设置大学医院。患者1896名连续的CAD患者转诊可能与诱导型心肌缺血有关的症状。测量使用可通过单光子发射计算机断层摄影术进行的心肌灌注成像以及冠状动脉造影和部分血流储备测量来判断是否存在可诱导的心肌缺血。工作人员对裁决的循环hs-cTn浓度不知情。评估了以前在大多数无症状的CAD患者中得出的hs-cTnI临界值2.5 ng / L。预先定义的目标绩效标准是至少90％的阴性预测值（NPV）和至少90％的敏感性，用于排除可诱导的心肌缺血。敏感性分析基于使用hs-cTnT分析和替代性hs-cTnI分析的测量结果，分析灵敏度更高（检测限，0.1 ng / L）。结果总体上，有865例患者（46％）患有可诱发的心肌缺血。hs-cTnI临界值为2.5 ng / L，排除了可诱导的心肌缺血，其NPV为70％（95％CI，64％至75％），敏感性为90％（CI，88％至92％）。没有hs-cTnI截止值达到预定义为目标的两个性能特征。同样，使用hs-cTnI或hs-cTnT的替代测定法，没有截止值达到目标性能：hs-cTnT浓度低于5 ng / L时产生的NPV为66％（CI，59％至72％），hs-cTnI浓度小于2 ng / L的NPV为68％（CI为62％至74％）。局限性数据是在使用中央裁决的大型单中心诊断研究中生成的。结论在有症状的CAD患者中，非常低的hs-cTnI浓度，包括hs-cTnI浓度低于2.5 ng / L，通常不能使使用者安全地排除可诱发的心肌缺血。主要资金来源欧盟，瑞士国家科学基金会，技术与创新委员会（Innosuisse），瑞士心脏基金会，巴塞尔心血管研究基金会，巴塞尔大学，巴塞尔大学医院，罗氏，雅培和Singulex。