Clinical Application Of High-sensitivity Troponin ? Concentrations And Changes In Chinese Populations For Acute Myocardial Infarction Diagnosis

Objective According to ARCHITECT hs-TnI of 2015 European Society of Cardiology(ESC)Non-ST-segment acute coronary syndrome(NSTE-ACS)guidelines,we aimed to determine feasibility and accuracy of the 1-hour diagnostic algorithm and the 3-hour diagnostic algorithm,to investigate the diagnostic value of myocardial infarction in Chinese patients,and further to explore hs-TnI clinical application procedure suitable for Chinese populations.Methods All patients with suspected coronary heart diseases(CHD)or acute coronary syndrome(ACS)who signed the consent were enrolled consecutively between January 2017 to January 2019 in emergency department(ED)of Fuwai Hospital.The cTn concentrations were analyzed with ARCHITECT hs-TnI assays at patient baseline presentation,1 hour and 3 hours after.Laboratory judgment based on hs-TnI levels was performed independently according to the hs-TnI 1-hour and 3-hour algorithms recommended by 2015 ESC NSTE-ACS guidelines.All clinical information and blood tests were recorded and obtained according to routine clinical algorithms.Clinical judgment,as the final diagnosis and gold standard,was made by cardiologists according to emergency diagnosis routine and clinical data,who were not involved in the study design and were not informed the results of ARCHITECT hs-TnI.Finally,we performed the statistic analysis.Results We recruited 800 patients and eliminated 52 due to the deficiency of key information,so there are 748 patients in our analysis with a median age of 62 years old,and male of 466(62.2%).In medical history,there were 468(62.6%)of hypertension,225(30.1%)of diabetes,459(61.4%)of hyperlipidemia,354(47.3%)of coronary heart disease,and 113(15.1%)of myocardial infarction respectively.Among the patients,206(27.5%)were acute myocardial infarction judged by routine clinical algorithms with 148(71.8%)male myocardial infarction patients.In laboratory judgement,there were 219(29.3%),199(26.8%),194(26.1%)myocardial infarction patients for 1-hour algorithm judgement and 3-hour judgement on overall and gender-specific criteria respectively.Comparing the 1-hour algorithm judgement results,the overall judgment and gender-specific judgment results of 3-hour algorithm,and 1-hour and 3-hour algorithm judgement results with the clinical judgment results,the consistency were 94.8%,95.6%,94.9%,and 95.0%,respectively.The sensitivity,specificity,positive predictive value,negative predictive value,for the 1-hour algorithm judgement were 100%,91.4%,88.1%,100%,respectively,for the overall judgment of 3-hour algorithm were 90.7%,97.4%,93.0%,96.5%,respectively,for the gender-specific judgment of 3-hour algorithm were 88.2%,97.4%,92.8%,95.6%,respectively,and for the 1-hour and 3-hour algorithm judgement were 95.1%,95.0%,87.9%,98.1%,respectively.In Chinese populations,the diagnostic values in ARCHITECT hs-TnI 1-hour algorithm on excluding myocardial infarction patients for A,B,C were 0.002ng/ml,0.006ng/ml,0.006ng/ml,on confirming myocardial infarction patients for D,E were 0.043ng/ml,0.007ng/ml,respectively.The diagnostic values for A,B,C,D,E were close to the ones in western populations.The percentage diagnostic value of ARCHITECT hs-Tnl 3-hour algorithm for myocardial infarction were ? change>50%,same as the one for western populations.Conclusion This study shows that ARCHITECT hs-TnI 1-hour algorithm and 3-hour algorithm recommended by 2015 ESC NSTE-ACS guidelines are highly feasible and accurate in Chinese populations.