Background Evaluation of patients with acute chest pain in emergencyrooms is time-consuming and expensive, and it often resultsin uncertain diagnoses. We prospectively investigated the usefulnessof bedside tests for the detection of cardiac troponin T andtroponin I in the evaluation of patients with acute chest pain.
Methods In 773 consecutive patients who had had acute chestpain for less than 12 hours without ST-segment elevation ontheir electrocardiograms, troponin T and troponin I status (positiveor negative) was determined at least twice by sensitive, qualitativebedside tests based on the use of specific monoclonal antibodies.Testing was performed on arrival and four or more hours laterso that one sample was taken at least six hours after the onsetof pain. The troponin T results were made available to the treatingphysicians.
Results Troponin T tests were positive in 123 patients (16 percent),and troponin I tests were positive in 171 patients (22 percent).Among 47 patients with evolving myocardial infarction, troponinT tests were positive in 44 (94 percent) and troponin I testswere positive in all 47. Among 315 patients with unstable angina,troponin T tests were positive in 70 patients (22 percent),and troponin I tests were positive in 114 patients (36 percent).During 30 days of follow-up, there were 20 deaths and 14 nonfatalmyocardial infarctions. Troponin T and troponin I proved tobe strong, independent predictors of cardiac events. The eventrates in patients with negative tests were only 1.1 percentfor troponin T and 0.3 percent for troponin I.
Conclusions Bedside tests for cardiac-specific troponins arehighly sensitive for the early detection of myocardial-cellinjury in acute coronary syndromes. Negative test results areassociated with low risk and allow rapid and safe dischargeof patients with an episode of acute chest pain from the emergencyroom.
The assessment of patients with acute chest pain in the emergencyroom is a time-consuming diagnostic challenge. If the electrocardiogramreveals ST-segment elevation, the probability of acute myocardialinfarction is high, and further management is well established.However, the sensitivity of the electrocardiogram may be aslow as 50 percent,1,2,3,4 and up to 4 percent of patients withevolving myocardial infarctions are sent home inappropriately.5,6,7,8Electrocardiographic changes in patients with unstable anginaare even less specific.9 When the electrocardiogram fails toprovide conclusive diagnostic information, serial measurementsof creatine kinase and its MB isoenzyme are widely used fordecision making. This traditional biochemical gold standardfor myocardial-cell injury has limited prognostic power, however.10,11Accordingly, many patients are unnecessarily hospitalized andoccupy expensive beds in coronary care units.
Recently, it was shown that measurements of the cardiac-specificcontractile proteins troponin T and troponin I are superiorto conventional measurement of creatine kinase MB for the detectionof minor myocardial injury12,13 and are valid predictors ofadverse events in patients with acute coronary syndromes.10,11,14,15,16,17,18However, the use of troponin measurements in the emergency roomis impaired by the limited availability of refined analytictechniques and by the long turnover times. Newly developed bedsidetest kits that provide a qualitative result (positive or negative)within 15 to 20 minutes could represent a major advance in decisionmaking in emergency rooms.19,20,21 In this prospective study,we investigated the diagnostic and prognostic value of rapidbedside troponin T and troponin I testing for early triage inthe emergency room.
Methods
Patients
The study population consisted of 773 patients (317 women and456 men; mean [±SD] age, 62±11 years) who wererecruited from among 870 consecutive eligible patients of allages presenting between June 1, 1994, and March 31, 1996, tothe emergency room of the University Hospital in Hamburg, Germany.To be eligible, the patients had to have acute anterior, precordial,or left-sided chest pain lasting 12 hours or less that was unexplainedby obvious local trauma or abnormalities on chest films. Patientswith ST-segment elevations (n = 97) or with documented acutemyocardial infarctions during the preceding two weeks were excluded.The mean duration of the qualifying episode of chest pain was5.0±3.2 hours (less than 2 hours in 21 patients); thechest pain was continuous in 32.8 percent of patients and intermittentin 67.2 percent.
Study Protocol
The study protocol was approved by the ethics committee of theHamburg Medical Board. After oral informed consent had beenobtained from the patient, 10 ml of blood was collected within15 minutes after arrival for measurement of troponin T and I,and each patient underwent 12-lead electrocardiography. Thesetests were repeated four hours later. For patients who presentedless than two hours after the onset of chest pain, these testswere performed for a third time six hours after the onset ofpain, so that tests were performed in all patients at leastsix hours after the onset of pain.
The rapid troponin T test was routinely performed in the emergencyroom by a trained assistant, and the result was provided tothe treating physicians. The decision about the treatment ofeach patient was left to the physician on duty. The rapid troponinI test was performed on heparin-treated plasma in a separatelaboratory by a trained assistant blinded to the patient's data.Serum samples for quantitative measurements and rapid qualitativemeasurements of troponin I were kept at room temperature for20 minutes to allow clotting, then centrifuged at 3000 rpm for10 minutes and stored at -80°C.
Clinical data from the emergency room evaluation, includingthe history, results of the physical examination, results ofcardiac-enzyme tests, and interpretation of the electrocardiograms,were recorded as part of a detailed protocol by the physiciansin the emergency room.
Patients were followed until discharge from the hospital andfor 30 days thereafter by telephone or questionnaire to recordcardiac events (complete data were obtained for 97.2 percentof patients). Patients admitted to the hospital stayed for amean of 4.2±2.5 days. The study end points were deathfrom cardiac causes and nonfatal acute myocardial infarctionduring hospitalization (excluding the first 24 hours) or afterdischarge from the hospital, as shown by hospital records. Deathfrom myocardial infarction was counted only as a death fromcardiac causes, not as a myocardial infarction.
Electrocardiographic Criteria
On the basis of the interpretation by the physician on duty,each patient was placed into one of the following electrocardiographiccategories: ST-segment elevation >0.20 mV, suggestive ofacute myocardial infarction (exclusion criterion); ST-segmentdepression >0.15 mV, with or without T-wave inversion; T-waveinversion only; nondiagnostic electrocardiogram (paced rhythm,bundle-branch block); and normal electrocardiogram. All electrocardiogramswere reevaluated by an independent observer.
Definitions
Unstable angina was defined as type IIIB in the Braunwald classification.22An acute myocardial infarction in a patient without ST-segmentelevation was considered to be present when the total creatinekinase activity within 24 hours after admission was more thantwice the upper limit of normal associated with elevated creatinekinase MB.
Analytic Techniques
For qualitative determination of serum cardiac troponin T, weused a whole-blood rapid-assay device (Boehringer Mannheim,Mannheim, Germany).23 In 150 µl of whole blood treatedwith heparin, the cellular fraction was separated from the plasmawith a glass-fiber fleece. In this assay, immunocomplexes areformed by a cardiac-specific gold-labeled monoclonal antibodyand a biotinylated monoclonal antibody binding to a differentepitope of troponin T. The immunocomplexes are immobilized bymeans of streptavidin technology in the reading zone, indicatingby a color line the presence of troponin T in the sample ata concentration above the discriminator value of 0.18 ng permilliliter, within 20 minutes.19
The results were controlled quantitatively with a one-step enzymeimmunoassay (ES 300, Boehringer Mannheim). The lower limit ofdetection was 0.02 ng per milliliter, and a discriminator valueof 0.1 ng per milliliter was used.17 The interassay coefficientsof variation were 9.7 percent at 0.35 ng per milliliter and7.4 percent at 5.55 ng per milliliter.
The qualitative determination of serum cardiac troponin I wascarried out by a rapid assay with chromatographic immunologicsolid-phase technology (Spectral Diagnostics, Toronto).24 Thistest requires two color-labeled mouse monoclonal antibodiesand a biotinylated polyclonal goat capture antibody forminga sandwich complex with the troponin I molecule that adheresto streptavidin in the signal zone.21 Enrichment of color-labeledantibodies binding to troponin I (discriminator value, 0.10ng per milliliter) results in a color line within 15 minutes.
The results of the rapid troponin I assay were controlled quantitativelyby the Access Analyzer (Sanofi Diagnostics–Pasteur, Marnes,France), which is based on chemiluminescence and magnetic particles.25,26The limit of detection of this test is 0.03 ng per milliliter,and values of 0.1 ng or more per milliliter were consideredpositive. The day-to-day coefficient of variation was 9.5 percentat 0.2 ng per milliliter and 4.6 percent at 2.4 ng per milliliteraccording to internal controls.
The correspondence between the results of the rapid bedsidetests and the quantitative controls in 1479 samples was 94.8percent for troponin T and 98.7 percent for troponin I. A negativebedside-test result in the presence of a quantitative resultabove the predefined cutoff point (false negative) was foundfor troponin T in one sample and for troponin I in five samples.
In all samples, the concentration of creatine kinase MB wasdetermined with a Stratus II Analyzer (Dade, Miami) with a limitof detection of 0.4 ng per milliliter and a cutoff of 4.7 ngper milliliter.27 The interassay coefficient of variation was12.5 percent at 6 ng per milliliter and 6.3 percent at 35 ngper milliliter. The total creatine kinase activity was routinelymeasured at room temperature in the emergency room laboratoryby a Hitachi 717 colorimeter (Boehringer Mannheim) with a cutoffpoint of 80 units per liter in men and 70 units per liter inwomen. All biochemical analyses were performed by techniciansunaware of the patients' histories and the results of the rapidassays for troponin T.
Statistical Analysis
All results for continuous variables are expressed as means±SD. The Mann–Whitney test was used to comparecontinuous variables between two subgroups. The P values forcomparisons of categorical variables were generated by the chi-squaretest for proportions with appropriate degrees of freedom, andP values of less than 0.05 according to the two-sided McNemartest were considered to indicate statistical significance. Thenegative predictive value was calculated as the percentage ofall negative test results observed that were true negative results.Stepwise logistic-regression analysis was used to adjust forthe effects of possible confounding by clinical, electrocardiographic,and cardiac-marker differences on the rates of mortality andinfarction during follow-up.28,29 All variables in the modelwere dichotomous. Relative risk was expressed in terms of oddsratios with 95 percent confidence intervals. All calculationswere done with SPSS 6.1 (SPSS, Chicago) or StatXact-3 (CytelSoftware, Cambridge, Mass.).
Results
Final Clinical Diagnoses
Of 773 consecutive patients without ST-segment elevation presentingto the emergency room with acute chest pain, 47 (6 percent)had a final diagnosis of acute myocardial infarction on thebasis of routine measurements of creatine kinase activity within24 hours after arrival. Among the other 726 patients, unstableangina was diagnosed in 315, stable angina in 121, pulmonaryembolism in 12, acute heart failure in 15, and myocarditis in5; 258 patients had no evidence of coronary heart disease.
A total of 487 patients (63 percent) were admitted to the hospital,including 224 (29 percent) admitted to the intensive care unit.All patients with acute myocardial infarction or unstable anginawere admitted.
Troponin Results and Clinical Diagnoses
Of the 773 patients, 123 (16 percent) had at least one positivebedside-test result for troponin T, and 171 (22 percent) hadat least one positive test for troponin I (P<0.001 by two-sidedMcNemar test). Patients with positive test results presentedto the hospital earlier than patients with negative results(3.1 vs. 5.4 hours after the beginning of pain, P<0.001 bythe Mann–Whitney test) and were younger (mean age, 57.6vs. 62.5 years; P<0.006 by the Mann–Whitney test).On arrival, 71 patients (9 percent) had a positive troponinT result, and 109 patients (14 percent) had a positive troponinI result. In the second test, done approximately four hourslater, 51 additional patients had a positive troponin T resultand 61 additional patients had a positive troponin I result.In the third test, which was performed in the 21 patients withpain of less than two hours' duration on arrival, 1 additionalpatient had a positive troponin T result, and 1 had a positivetroponin I result. Thus, among the patients who had at leastone positive result for troponin, only 58 percent of those witha positive troponin T result and 64 percent of those with apositive troponin I result had a positive result when they werefirst tested on arrival at the emergency room.
Among 47 patients with acute myocardial infarction but withoutST-segment elevation, 24 (51 percent) had a positive troponinT test on arrival, and 44 (94 percent) had a positive troponinT test four hours later. Thirty-one (66 percent) of these patientshad a positive troponin I test on arrival, and all of them hada positive troponin I test four hours later. Creatine kinaseMB was elevated in 25 of these patients (53 percent) on arrivaland in 43 patients (91 percent) four hours later.
Among 315 patients with unstable angina, 70 (22 percent) hadat least one positive troponin T test, and 114 (36 percent)had at least one positive troponin I test. Creatine kinase MBwas elevated in only 16 (5 percent) of the patients with unstableangina in any test.
Among the other patients with at least one positive troponinT test, one had pulmonary embolism, one had cardiac failure,and one had suspected myocarditis. Among the other patientswith at least one positive troponin I test, two had pulmonaryembolism, five had cardiac failure, two had myocarditis, andone had unexplained chest pain. Seven patients had a positivetroponin T test but a negative troponin I test. In six of thesepatients, this result was associated with renal failure andis therefore regarded as a false positive result.
Creatine kinase MB was elevated in 27 patients who had no detectabletroponins. In none of these patients could an acute myocardialischemic event be confirmed during clinical follow-up.
Troponins and the Electrocardiogram
Electrocardiographic ST-T alterations other than ST-segmentelevations were found in 355 patients (46 percent); 158 patientshad ST-segment depressions, and 197 patients had T-wave inversions.In 87 patients (11 percent), the electrocardiogram was nondiagnostic(paced rhythm, bundle-branch block); 23 of these patients hadmyocardial infarctions. Among the other patients with myocardialinfarctions, 8 had ST-segment depressions, 15 had T-wave inversions,and 1 had a normal electrocardiogram.
Among 158 patients with ST-segment depressions, 51 patients(32 percent) had at least one positive troponin T test, and88 patients (56 percent) had at least one positive troponinI test. Among 197 patients with T-wave inversions, 12 patients(6 percent) had at least one positive troponin T test, and 9patients (5 percent) had at least one positive troponin I test.Among 331 patients with normal electrocardiograms, 32 patients(10 percent) had at least one positive troponin T test, and33 patients (10 percent) had at least one positive troponinI test. Among 87 patients with nondiagnostic electrocardiograms,28 patients (32 percent) had at least one positive troponinT test, and 41 patients (47 percent) had at least one positivetroponin I test.
Follow-Up Events
All patients with a positive troponin T test were admitted tothe hospital. Of the 286 patients who were not admitted, 7 patientshad a positive troponin I test, as determined in a separatelaboratory. Two of these patients had adverse events duringfollow-up (one death after 23 days and one nonfatal myocardialinfarction after 5 days).
Cardiac events occurred in 34 patients during follow-up. Fouradditional deaths from noncardiac causes were not included inthe evaluation. All 20 deaths included in the evaluation wererelated to cardiac disease or were sudden deaths; 11 of themoccurred in the hospital (Table 1). Nine of the 14 myocardialinfarctions occurred during the initial hospitalization.
Table 1. Numbers of Deaths and Nonfatal Acute Myocardial Infarctions Occurring in the Hospital and within 30 Days after Discharge, According to Troponin Status.
Four of the 20 patients who died had negative results on alltroponin T tests, and 1 had negative results on all troponinI tests. Three of the 14 patients who had myocardial infarctionshad negative results on all troponin T tests, and 1 had negativeresults on all troponin I tests. The second test performed fourhours after arrival (or, for patients who presented less thantwo hours after the onset of pain, the third test performedsix hours after the onset of pain) considerably increased thepredictive value (Table 2). The total event rate was 1.1 percentin patients in whom all troponin T tests were negative and 0.3percent in patients in whom all troponin I tests were negative(P<0.001 by the McNemar test). Thus, the negative predictivevalue was 98.9 percent for troponin T and 99.7 percent for troponinI. Only one patient with negative results on all troponin Ttests had a cardiac event within two weeks after discharge (Figure 1).
Table 2. Cardiac Events as Predicted by Elevated Serum Markers and Electrocardiographic Abnormalities on Arrival and Four Hours Later (or at Least Six Hours after Onset of Pain).
Figure 1. Survival without Cardiac Events (Death or Nonfatal Acute Myocardial Infarction) during 30 Days of Follow-up, According to Troponin T and Troponin I Status.
Events that occurred during the initial 24 hours are excluded.
Table 3 shows event rates according to the electrocardiographicresults and the results of the troponin tests. No cardiac eventoccurred in a patient with a normal electrocardiogram and anegative troponin I test.
Table 3. Cardiac Events According to Electrocardiographic Findings and Troponin Status.
Table 4 shows the relative value of serum markers and electrocardiographicresults for the prediction of major cardiac events. After theelectrocardiogram is forced into the logistic-regression modelfirst, the independent prognostic value of troponin I and troponinT remains evident. If the results of tests for creatine kinaseMB and troponins are available, the electrocardiogram providesno additional prognostic value.
Table 4. Relative Value of Serum Markers and Electrocardiographic Abnormalities as Predictors of Cardiac Events at 30 Days.
Discussion
In recent years several studies have shown that detectable bloodlevels of cardiac-specific troponin T and troponin I in patientswith acute coronary syndromes are associated with unfavorableoutcomes.10,11,14,15,16,17,18 In the present prospective study,these findings were extended to patients arriving at the emergencyroom with acute chest pain. The aim was to investigate how clinicaldecision making for patients with acute chest pain but withoutST-segment elevation may be facilitated and improved. Accordingly,the troponin T test result obtained at the point of care inthe emergency room was made available to the treating physicians.
When the troponin T bedside test was routinely used, no patientwith myocardial infarction was inappropriately discharged. Whenpatients were tested four hours after arrival (or six hoursafter the onset of pain for those who presented less than twohours after the onset of pain), 94 percent of patients withmyocardial infarction and without ST-segment elevation had apositive test for troponin T, and 100 percent had a positivetest for troponin I. However, the diagnostic specificity ofthese tests for myocardial infarction was low, since 22 percentof patients with unstable angina had a positive result for troponinT and 36 percent of them had a positive result for troponinI.
In patients with negative test results, the risk of major cardiacevents during the 30-day follow-up period was very low. Only1.1 percent of patients with negative troponin T results and0.3 percent of patients with negative troponin I results hadnonfatal myocardial infarctions or died. Only one patient witha negative troponin T result had a cardiac event within twoweeks after discharge (Figure 1). Because all patients witha positive troponin T result were admitted to the hospital,the event rate may have been lower than that with conventionaldecision making. However, the primary aim of this study wasto demonstrate that two negative test results on admission andfour hours later (or at least six hours from the onset of chestpain) allow safe early discharge.
Our experience shows that highly sensitive bedside tests fortroponin T and troponin I result in more accurate diagnosesthan do previous, more time-consuming methods30,31,32,33 andallow safer and more rapid decision making for most patientswith acute chest pain. A high-risk acute coronary syndrome isvery unlikely in a patient with a negative test result. Allpatients with at least one positive test result should be admittedto the hospital and will require further evaluation, includingcoronary angiography in most cases. A single test at the timeof arrival is inadequate for clinical decision making.34,35
Previous studies demonstrated that increasing troponin levelswere correlated with a higher risk of future adverse events.11,14,18However, for routine clinical practice, the qualitative resultsobtained with the bedside tests seem to be sufficient. The analyticreliability of the tests was confirmed in our study by quantitativecontrols. The slightly higher sensitivity of the troponin Itest as compared with the troponin T test may be related todifferent release kinetics and different limits of detectionof the versions of the test that are currently available.
The finding of false positive results for troponin T, but nottroponin I, in patients with renal failure may, however, representa true difference between the two tests.36 Both test systemsare superior to creatine kinase MB measurements with respectto sensitivity and specificity, as was previously shown forthe quantitative assays.13,14
These new biochemical tests should not be considered substitutesfor the electrocardiogram, which remains the unquestioned standardfor the diagnosis of acute myocardial infarction and the initiationof thrombolytic therapy.37 However, in patients without ST-segmentelevation and in patients with unstable angina, thrombolysisis of no established benefit.33,37 Troponin measurements allowthe detection of minor myocardial injuries that are most likelydue to thrombotic microembolization from ruptured atheroscleroticplaques.38,39 Therapy for patients in this high-risk group stillneeds to be established, but the use of glycoprotein IIb/IIIareceptor inhibitors may be a promising strategy.40
The troponin tests cannot replace the clinical evaluation ofthe patient with chest pain.32 Life-threatening noncardiac diseasesneed to be excluded. However, this new diagnostic tool, withits superior predictive value, should be made available to emergencyrooms and chest-pain units.
We are indebted to the emergency room physicians for collectingthe data and to Sabine Wohlrath, Gesche Voss, Jan Schneider,and Robert Möller for expert technical support.
Source Information
From the Department of Cardiology (C.W.H., B.U.G., C.H., T.M.), the Medical Clinic (G.K.), and the Institute of Mathematics and Computer Science in Medicine (J.B.), University Hospital Eppendorf, Hamburg, Germany.
Address reprint requests to Dr. Hamm at the Department of Cardiology, Medical Clinic, University Hospital Eppendorf, Martinistrasse 52, D-20246 Hamburg, Germany.
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