| Acute chest pain is regarded as a common cause in emergency department,and acute coronary syndrome(ACS)is one of the main causes of high-risk chest pain.Therefore,how to carry out diagnosis and risk stratification for suspected ACS patients quickly,accurately and effectively in a short time,shorten the time from the first medical contact to treatment,screen out low-risk chest pain patients quickly,slow down the detention in emergency room and save medical resources are still important clinical challenges.The application of high-sensitivity troponin(hs-cTn)has opened up a new pattern of diagnosis,prognosis and risk stratification in patients with ACS.Based on the hs-cTn concentration and its changes,various diagnostic processes for patients with suspected ACS to determine non-ST segment elevation myocardial infarction(NSTEMI)are constantly updated.However,its application research in Chinese population remains imperfect.This study is a multicenter,prospective and observational study.Architect hs-cTnI detection method was selected,so as to explore the diagnostic efficacy of 0/3-hour and 0/1hour hs-cTnI concentration and its changes in judging the application of acute myocardial infarction diagnostic process in Chinese population and the predictive value of adverse events,further propose and explore the effectiveness and safety of the process with a simplified process(chest pain time is not considered in 0/1 h process),and provide further basis for promoting the application of hs-cTnI in Chinese population.Part Ⅰ:Analysis on the clinical application of 0/3-hour hs-cTnI concentration and its changes in judging acute myocardial infarctionObjective:To explore the feasibility and accuracy of 0/3-hour hs-cTnI concentration and its changes in determining the diagnostic process of acute myocardial infarction,and investigate the application value of gender-specific threshold in this process.Methods:Patients with acute chest pain suspected ACS were selected from emergency department of Fuwai Hospital,The First Affiliated Hospital of Sun Yat-sen University and Nanjing First Hospital from January 2017 to September 2020.Hs-cTnI detection was carried out for the included patients at the time of visit(0 h)and 3 h after visit.According to the 0/3-hour hs-cTnI concentration and its changes recommended in the management guidelines of Non-ST Segment Elevation Acute coronary syndrome(NSTEACS)issued by the European Society of Cardiology(ESC)in 2015,the overall population threshold and gender-specific threshold of hs-cTnI were used to test and judge NSTEMI respectively.According to the routine diagnosis and treatment data of emergency department,the clinical judgment was performed according to the third global definition of myocardial infarction by cardiovascular emergency doctors who did not participate in the project design and did not know the results of hs-cTnI test.The sensitivity,specificity,negative predictive value(NPV)and positive predictive value(PPV)of 0/3-hour hs-cTnI concentration and its change in the determination of NSTEMI in Chinese population were calculated based on the gold standard of clinical judgment,and the diagnostic efficacy was analyzed.Results:A total of 1527 patients with a median age of 63 years old were included in this part,including 947 males(62.0%).Among them,there were 400 cases(26.2%)in NSTEMI group and 1127 cases(73.8%)in non-NSTEMI group.According to the overall population threshold of the recommended process in the guidelines,NSTEMI was ruled out for 1092 patients(71.5%),and 435 patients(28.5%)was ruled in NSTEMI.The consistency rate with the clinical judgment results of the study was 93.3%,the sensitivity of rule-out diagnosis was 91.5%(95%CI:88.2-94.0%),NPV was 96.9%(95%CI:95.697.8%),and the specificity of rule-in diagnosis was 93.8%(95%CI:92.3-95.2%)and PPV was 84.1%(95%CI:80.3-87.4%).According to the gender-specific threshold of the process,the proportion of male and female patients who ruled out and ruled in NSTEMI was not statistically different from that of the whole population process(P>0.05).The accuracy of gender-specific process was 92.9%,the sensitivity of ruled out was 91.0%(95%CI:87.6-93.5%),NPV was 96.7%(95%CI:95.4-97.6%),the specificity of ruled in was 93.7%(95%CI:92.1-95.1%),PPV was 83.8%(95%CI:80.0-97.2%).Conclusion:The 0/3-hour hs-cTnI concentration and its changes have a good diagnostic efficacy in determining the diagnostic process of NSTEMI in Chinese population,and the application of gender-specific threshold has no more benefit in diagnostic efficacy.Part II:Analysis on the clinical application of 0/1-hour hs-cTnI concentration and its changes in judging acute myocardial infarctionObjective:To explore the feasibility and accuracy of 0/1-hourhs-cTnI concentration and its changes in judging the diagnostic process of acute myocardial infarction and its predictive value of this process for adverse events.Methods:Based on the selected population in this study,hs-cTnI detection was carried out for the selected patients at the time of visit(0 h)and 1 h after visit.According to the 0/1-hour hs-cTnI concentration and its changes recommended in ESC NSTE-ACS management guidelines in 2015 and 2020,the judgment process and corresponding threshold values forjudging NSTEMI were tested and judged respectively.According to the routine diagnosis and treatment data of emergency department,the clinical judgment was made.The sensitivity,specificity,NPV and PPV of 0/1-hour hs-cTnI concentration and its changes recommended in the above guidelines for the diagnosis of NSTEMI in Chinese population were analyzed and compared,and the diagnostic efficacy of this process was further compared among different subgroups(age,gender,chest pain time and glomerular filtration rate).The selected patients were followed up for 30 and 180 days.The main endpoint event was the composite endpoint of recurrent/new myocardial infarction(excluding NSTEMI at the time of admission),unplanned vascular remodeling and cardiovascular death,and the secondary endpoint event was all-cause death.COX analysis was carried out in groups according to the judgment results of 0/1-hour process.Results:1534 patients were included in this part with a median age of 63 years old,including 952 males(62.1%).Among them,402 patients(26.2%)were clinically judged as NSTEMI and 1132 patients(73.8%)were non-NSTEMI.The consistency rate of 0/1hour hs-cTnI concentration and its changes recommended by ESC NSTE-ACS guidelines in 2015 was 92.4%,the sensitivity of rule-out diagnosis was 99.5%(95%CI:98.0-99.9%),NPV was 99.7%(95%Cl:98.8-0.99.9%),and the specificity of rule-in diagnosis was 92.6%(95%CI:90.9-94.0%)and PPV was 81.9%(95%CI:78.0-85.2%).In 2020,the consistency rate between ESC NSTE-ACS guidelines and clinical judgment results was 92.6%,sensitivity was 99.5%(95%CI:98.0-99.9%),NPV was 99.7%(95%CI:98.899.9%),specificity was 92.8%(95%CI:91.0-94.2%),and PPV was 82.2%(95%CI:78.385.5%).There was no significant difference in sensitivity,specificity,NPV and PPV between 2015 and 2020 ESC NSTE-ACS guidelines(P>0.05).In the subgroup analysis of different age,sex,chest pain time and glomerular filtration rate,NPV and PPV of this process were all>99%and 70%,respectively.A total of 1459 patients(95.1%)completed follow-up.During the 30-day follow-up,the 0/1-hour judgment process had no end-point events in rule out NSTEMI group;by the 180-day follow-up,the risk of primary endpoint events of rule in NSTEMI group was higher than that in rule out NSTEMI group(2015 guideline process:HR=5.094,95%CI 1.677-15.480,P=0.004;2020 guideline process:HR=5.138,95%CI 1.691-15.610,P=0.004),and the risk of secondary endpoint events was also higher than that in rule out NSTEMI group(2015 guideline process:HR=8.256,95%CI 2.420-28.170,P<0.001;2020 guideline process:HR=8.327,95%CI 2.44-28.41,P<0.001).Conclusion:The 0/1-hour hs-cTnI concentration and its changes have good diagnostic efficacy and application value in Chinese population.There is no need to set specific thresholds according to age,gender,chest pain time and glomerular filtration rate,and the process has certain predictive value for the risk of adverse events at 30 and 180 days.Part Ⅲ:Comparison of the efficacy of hs-cTnI concentration and its changes in judging acute myocardial infarction by different processesObjective:To compare the difference of diagnostic efficacy between 0/1-hour and 0/3-hour hs-cTnI concentration and its changes in determining the diagnostic process of acute myocardial infarction.Methods:Based on the selected population of this study,this part included all the patients who completed the hs-cTnI test at the time of visit(0 h),1 h after visit and 3 h after visit,and laboratory adjudication was determined according to the 0/1-hour and 0/3hour hs-cTnI concentration and its changes recommended in ESC NSTE-ACS guidelines in 2020.According to the routine diagnosis and treatment data of emergency department,the clinical judgment was made.The sensitivity,specificity,NPV and PPV of NSTEMI were analyzed and compared between different processes.Results:1525 patients were included in this part with a median age of 63 years old,including 946 males(62.0%).According to clinical judgment,there were 399 cases(26.2%)in NSTEMI group and 1126 cases(73.8%)in non-NSTEMI group.1128 patients(74.0%)could rule out or rule in NSTEMI at 1 hour according to the process of 0/1-hour hs-cTnI concentration and its changes.The sensitivity and NPV of 0/1-hour process were 99.5%and 99.7%respectively,which were higher than 91.5%and 96.9%of 0/3-hour process in ruling out NSTEMI(P<0.001).In the diagnosis of NSTEMI,the specificity of 0/1-hour process was 92.7%and PPV was 82.1%,which had no statistical difference with 93.8%and 84.1%of 0/3-hour process(P values were 0.273 and 0.433,respectively).Conclusion:The efficiency of ruling out NSTEMI in 0/1-hour hs-cTnI concentration and its changes in patients with suspected ACS is better than that of 0/3-hour,and both are equally effective of ruling in NSTEMI,so as to shorten the judgment time,0/1-hour is recommended as the preferred strategy for patients with suspected ACS.Part Ⅳ:Clinical application of a simplified 0/1-hour hs-cTnI concentration and its change in judging acute myocardial infarctionObjective:To propose and explore the feasibility and accuracy of a simplified 0/1 h hs-cTnI concentration and its changes in judging the diagnostic process of acute myocardial infarction without considering chest pain time.Methods:Based on the selected population of this study,this part included patients who completed the hs-cTnI test at the time of visit(0 h)andl h after the visit.In this part,the process of judging NSTEMI was simplified according to 0/1-hour hs-cTnI concentration and its changes recommended by ESC NSTE-ACS management guidelines in 2020.Chest pain time was no longer considered when applying 0 h for ruling NSTEMI,and laboratory adjudication were carried out according to the simplified 0/1 h process;according to the routine diagnosis and treatment data of emergency department,the clinical judgment was made.The sensitivity,specificity,NPV and PPV of the simplified 0/1-hour process for ruling NSTEMI were calculated with clinical judgment as gold standard,and compared with the standard process recommended by the guidelines to analyze the diagnostic efficacy and application value of the simplified procedure.Results:1534 patients were included in this part with a median age of 63 years old,including 952 male patients(62.1%).Among them,there were 402 cases(26.2%)in NSTEMI group and 1132 cases(73.8%)in non-NSTEMI group.The accuracy of the simplified 0/1-hour hs-cTnI concentration and its changes was 92.5%,the sensitivity of rule out was 99.0%(95%CI:97.3-99.7%),NPV was 99.4%(95%CI:98.4-99.8%),the specificity of rule in was 92.8%(95%CI:91.1-94.2%),PPV was 82.3%(95%CI:78.485.6%).Compared with the 0/1-hour process recommended by ESC NSTE-ACS guidelines in 2020,the simplified 0/1-hour process enables more patients to rule out NSTEMI at 0 h(39.8%and 24.1%,respectively,P<0.001),without reducing sensitivity,specificity,NPV and PPV(P>0.05).Conclusion:The simplified 0/1-hour hs-cTnI concentration and its change without considering the time of chest pain has a good diagnostic efficiency for ruling acute myocardial infarction and can further accelerate the shunt of patients with acute chest pain suspected of ACS. |
