High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction

Boeddinghaus, Jasper; Nestelberger, Thomas; Twerenbold, Raphael; Koechlin, Luca; Meier, Mario; Troester, Valentina; Wussler, Desiree; Badertscher, Patrick; Wildi, Karin; Puelacher, Christian; Lavallaz, Jeanne du Fay de; Giménez, María Rubini; Zimmermann, Tobias; Hafner, Benjamin; Potluková, Eliška; Miró, Òscar; Martín‐Sánchez, Francisco Javier; Keller, Dagmar I.; Reichlin, Tobias; Müeller, Christian; Walter, Joan; Strebel, Ivo; Kozhuharov, Nikola; Freese, Michael; Fuenzalida, Carolina; Stelzig, Claudia; Gualandro, Danielle Menosi; Michou, Eleni; Meissner, Kathrin; Kulangara, Caroline; Shrestha, Samyut; Fahrni, Gregor; Oßwald, Stefan; López, Beatriz; Adrada, Esther Rodríguez; Ganovská, Eva; Lohrmann, Jens; Kloos, Wanda; Steude, Jana; Buser, Andreas; Eckardstein, Arnold von; Morawiec, Beata; Kawecki, Damian; Nowalany-Kozielska, Ewa; Muzyk, Piotr; Geigy, Nicolas; Rentsch, Katharina

doi:10.1373/clinchem.2018.300061

Cited by 68 publications

(33 citation statements)

References 39 publications

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“…[2] To date, biomarker measurement for cardiomyocyte injury, preferably high-sensitivity cardiac troponin (hsTnI), is mandatory in all patients with suspected NSTEMI due to the high sensitivity and speci city. [2,39,40] However, several concerns should be considered in current practice. First, the guidelines suggest the second cardiac troponin assessment to be performed 1-3 hours after the rst blood test in uncon rmed cases.…”

Section: Discussionmentioning

confidence: 99%

A Deep-learning Algorithm With the Real World Validation for Detecting Acute Myocardial Infarction

Liu¹,

Lin²,

Tsai³

et al. 2020

Preprint

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BackgroundThe initial detection and diagnosis of ST-segment or non-ST-segment elevation myocardial infarction (STEMI or NSTEMI) definitely rely on a 12-lead electrocardiogram (ECG). Delay or misdiagnosis is not unusual by subjective interpretation. Our aim is to develop a DLM as a diagnostic support tool to detect MI based on a 12-lead ECG and to evaluate the performance of this model.MethodsThis study included 1,051 ECGs from 737 coronary angiography (CAG)-validated STEMI patients, 697 ECGs from 287 CAG-validated NSTEMI patients, and 140,336 not-MI ECGs from 76,775 patients at emergency departments. DLM was trained and validated for the performance using 80% and 20% of the ECGs, respectively. A human-machine competition was conducted. The area under the receiver operating characteristic curve (AUC), sensitivity, and specificity were used to evaluate the performance of DLM and experts. STEMI versus not-STEMI, and MI versus not-MI were evaluated by DLM.ResultsThe AUCs of DLM for identifying STEMI and MI were 0.976 and 0.944 in the human-machine competition, respectively, which were significantly better than those of our best clinicians. In the real world setting, DLM presented with AUC of 0.995/0.916 with corresponding sensitivities of 96.9%/77.0%, and specificities of 96.2%/92.9% in the identification of STEMI and MI, respectively. Furthermore, DLM demonstrated sufficient diagnostic capacity for STEMI without the aid of troponin I (TnI) (AUC= 0.996) with corresponding sensitivity and specificity of 98.4% and 96.9%. The AUC of combined DLM and the first recorded TnI for the detection of NSTEMI were increased to 0.978 with corresponding sensitivity and specificity of 91.6% and 96.7%, which was better than that of DLM (0.877) or TnI (0.949) alone. ConclusionsDLM may serve as a diagnostic decision tool to assist intensive or emergency medical system-based networks and frontline physicians in identifying STEMI and NSTEMI in a timely and precise manner to prevent delay or misdiagnosis, and thereby to facilitate subsequent reperfusion therapy.

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Section: Discussionmentioning

confidence: 99%

A Deep-learning Algorithm With the Real World Validation for Detecting Acute Myocardial Infarction

Liu¹,

Lin²,

Tsai³

et al. 2020

Preprint

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“…data where absolute deltas with this assay that exceed predefined thresholds of 4 ng/L at 1 hour 2 and 5 ng/L 3 at 2 hours, even among those with low initial troponins, were associated with acute MI. This may be attributable to the cohort enrolled by Peacock et al, where the prevalence of MI was lower (11.2% vs. 15.4% 2 and 14.5% 3 ) and the time from symptom onset to first blood draw which exceeded 3 hours for the vast majority of enrolled patients. From a care delivery perspective, demonstration that the 10% CV cut‐point provides acceptable safety is key as it enables rule‐out in more than twice as many people (58% vs. 24%) compared to the LoQ.…”

mentioning

confidence: 81%

Prognosis, Prognosis, Wherefore Art Thou Prognosis?

Levy

2020

Academic Emergency Medicine

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“…The amount of analyte in the sample is determined from a stored, multipoint calibration curve, the analytical performance of which has been previously described. [8][9][10][11][12][13][14][15] Data Analysis For this analysis, the URL for both sexes was defined as 17.9 ng/L and was derived from data that served as part of the FDA submission for this assay, as is documented in the package insert. 7,16 The appropriate sample size was a priori determined for the FDA submission, but not for this secondary analysis.…”

Section: Methodsmentioning

confidence: 99%

“…These factors further underscore the need for prospective studies with prespecified endpoints and adequate statistical power to confirm our findings. Also, while some have supported the use of sex-specific cutpoints for the diagnosis of AMI, in regard to this assay, proof of the consequence of applying sex-specific cutpoints [12][13][14] awaits the completion of additional investigations. Finally, patients presented a median of 3 hours after the onset of symptoms and had blood collected for this study an hour later, so that outcomes in individuals presenting earlier warrant further investigation.…”

Section: Limitationsmentioning

confidence: 99%

Myocardial Infarction Can Be Safely Excluded by High‐sensitivity Troponin I Testing 3 Hours After Emergency Department Presentation

Peacock

Christenson

Diercks

et al. 2020

Academic Emergency Medicine

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Background The accuracy and speed by which acute myocardial infarction (AMI) is excluded are an important determinant of emergency department (ED) length of stay and resource utilization. While high‐sensitivity troponin I (hsTnI) >99th percentile (upper reference level [URL]) represents a “rule‐in” cutpoint, our purpose was to evaluate the ability of the Beckman Coulter hsTnI assay, using various level‐of‐quantification (LoQ) cutpoints, to rule out AMI within 3 hours of ED presentation in suspected acute coronary syndrome (ACS) patients. Methods This multicenter evaluation enrolled adults with >5 minutes of ACS symptoms and an electrocardiogram obtained per standard care. Exclusions were ST‐segment elevation or chronic hemodialysis. After informed consent was obtained, blood samples were collected in heparin at ED admission (baseline), ≥1 to 3, ≥3 to 6, and ≥6 to 9 hours postadmission. Samples were processed and stored at –20°C within 1 hour and were tested at three independent clinical laboratories on an immunoassay system (DxI 800, Beckman Coulter). Analytic cutpoints were the URL of 17.9 ng/L and two LoQ cutpoints, defined as the 10 and 20% coefficient of variation (5.6 and 2.3 ng/L, respectively). A criterion standard MI diagnosis was adjudicated by an independent endpoint committee, blinded to hsTnI, and using the universal definition of MI. Results Of 1,049 patients meeting the entry criteria, and with baseline and 1‐ to 3‐hour hsTnI results, 117 (11.2%) had an adjudicated final diagnosis of AMI. AMI patients were typically older, with more cardiovascular risk factors. Median (IQR) presentation time was 4 (1.6–16.0) hours after symptom onset, although AMI patients presented ~0.5 hour earlier than non‐AMI. Enrollment and first blood draw occurred at a mean of ~1 hour after arrival. To evaluate the assay's rule‐out performance, patients with any hsTnI > URL were considered high risk and were excluded. The remaining population (n = 829) was divided into four LoQ relative categories: both hsTnI < LoQ (Lo‐Lo cohort); first hsTnI < LoQ and 2nd > LoQ (Lo‐Hi cohort); first > LoQ and second < LoQ (Hi‐Lo cohort); or both > LoQ (Hi‐Hi cohort). In patients with any hsTnI result <20% CV LoQ (Groups 1–3), n = 231 (23.9% ruled out), AMI negative predictive value (NPV) was 100% (95% confidence interval [CI] = 98.9% to 100%). In patients with any hsTnI below the 10% LoQ, n = 611 (58% rule out), AMI NPV was 100% (95% CI = 99.5% to 100%). Of the Hi‐Hi cohort (i.e., no hsTnI below the 10% LoQ, but both < URL), there were four AMI patients, NPV was 98.2% (95% CI = 95.4% to 99.3%), and sensitivity was 96.6. Conclusions Patients presenting >3 hours after the onset of suspected ACS symptoms, with at least two Beckman Coulter Access hsTnI < URL and at least one of which is below either the 10 or the 20% LoQ, had a 100% NPV for AMI. Two hsTnI values 1 to 3 hours apart with both < URL, but also >LoQ had inadequate sensitivity and NPV.

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High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction

Cited by 68 publications

References 39 publications

A Deep-learning Algorithm With the Real World Validation for Detecting Acute Myocardial Infarction

A Deep-learning Algorithm With the Real World Validation for Detecting Acute Myocardial Infarction

Prognosis, Prognosis, Wherefore Art Thou Prognosis?

Myocardial Infarction Can Be Safely Excluded by High‐sensitivity Troponin I Testing 3 Hours After Emergency Department Presentation

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