Two-Hour Algorithm for Rapid Triage of Suspected Acute Myocardial Infarction Using a High-Sensitivity Cardiac Troponin I Assay

Two-Hour Algorithm for Rapid Triage of Suspected Acute Myocardial Infarction Using a High-Sensitivity Cardiac Troponin I Assay
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DOI:
10.1373/clinchem.2019.305193
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发表时间:
2019-11-01
期刊:
影响因子:
9.3
通讯作者:
Mueller, Christian
Mueller, Christian
中科院分区:
医学1区
文献类型:
--
作者:
Nestelberger, Thomas;Boeddinghaus, Jasper;Mueller, Christian

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背景:我们旨在使用高灵敏度心肌肌钙蛋白I (hs-cTnI)-Access测定法推导并外部验证0/2-h算法。方法:我们在2项前瞻性诊断研究中纳入了出现急性心肌梗死(AMI)症状的急诊科患者。两名独立的心脏病专家裁决了最终的诊断,包括所有可用的医学信息,包括心脏成像。在呈现时和2 h后用盲法测量hs-cTnI-Access浓度。结果:衍生队列中1131例患者中有164例(14.5%)最终确诊为AMI。hs-cTnI-Access 0/2-h算法的排除定义为0-h hs-cTnI-Access浓度3 h(直接排除)或0-h hs-cTnI-Access浓度= 20 ng/L。在衍生队列中,这些截止值排除了55%的阴性预测值(NPV)为99.8% (95% CI, 99.3-100)和99.4% (95% CI, 96.5-99.9)的患者,排除了30%的阳性预测值(PPV)为73% (95% CI, 61.1 -79)的患者。在验证队列中,1280例患者中有88例(6.9%)最终确诊为AMI。这些截止值排除了77.9% NPV为99.8% (95% CI, 99.3-100)和97.7%敏感性(95% CI, 92.0-99.7)的患者,并排除了5.8% PPV为77% (95% CI, 65.8-86)的验证队列患者。结论:lhs-cTnI-Access 0/2-h算法用于AMI排除或纳入分诊的安全性和有效性非常高。(C) 2019美国临床化学协会
BACKGROUND: We aimed to derive and externally validate a 0/2-h algorithm using the high-sensitivity cardiac troponin I (hs-cTnI)-Access assay.METHODS: We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI) in 2 prospective diagnostic studies using central adjudication. Two independent cardiologists adjudicated the final diagnosis, including all available medical information including cardiac imaging. hs-cTnI-Access concentrations were measured at presentation and after 2 h in a blinded fashion.RESULTS: AMI was the adjudicated final diagnosis in 164 of 1131 (14.5%) patients in the derivation cohort. Ruleout by the hs-cTnI-Access 0/2-h algorithm was defined as 0-h hs-cTnI-Access concentration 3 h (direct rule-out) or a 0-h hs-cTnI-Access concentration = 20 ng/L. In the derivation cohort, these cutoffs ruled out 55% of patients with a negative predictive value (NPV) of 99.8% (95% CI, 99.3-100) and sensitivity of 99.4% (95% CI, 96.5-99.9), and ruled in 30% of patients with a positive predictive value (PPV) of 73% (95% CI, 66.1-79). In the validation cohort, AMI was the adjudicated final diagnosis in 88 of 1280 (6.9%) patients. These cutoffs ruled out 77.9% of patients with an NPV of 99.8% (95% CI, 99.3-100) and sensitivity of 97.7% (95% CI, 92.0-99.7), and ruled in 5.8% of patients with a PPV of 77% (95% CI, 65.8-86) in the validation cohort.CONCLUSIONS: Safety and efficacy of the lhs-cTnI-Access 0/2-h algorithm for triage toward rule-out or rule-in of AMI are very high. (C) 2019 American Association for Clinical Chemistry