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Performance of Novel High-Sensitivity Cardiac Troponin I Assays for 0/1-Hour and 0/2- to 3-Hour Evaluations for Acute Myocardial Infarction: Results From the HIGH-US Study.

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Date
2020-07
Authors
Nowak, Richard M
Christenson, Robert H
Jacobsen, Gordon
McCord, James
Apple, Fred S
Singer, Adam J
Limkakeng, Alexander
Peacock, William F
deFilippi, Christopher R
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Abstract
STUDY OBJECTIVE:We determine the accuracy of high-sensitivity cardiac troponin I (hs-cTnI), European-derived, rapid, acute myocardial infarction, rule-out/rule-in algorithms applied to a US emergency department (ED) population. METHODS:Adults presenting to the ED with suspected acute myocardial infarction were included. Plasma samples collected at baseline and between 40 and 90 minutes and 2 and 3 hours later were analyzed in core laboratories using the Siemens Healthineers hs-cTnI assays. Acute myocardial infarction diagnosis was independently adjudicated. The sensitivity, specificity, and negative and positive predictive values for rapid acute myocardial infarction rule-out/rule-in using European algorithms and 30-day outcomes are reported. RESULTS:From 29 US medical centers, 2,113 subjects had complete data for the 0/1-hour algorithm analyses. With the Siemens Atellica Immunoassay hs-cTnI values, 1,065 patients (50.4%) were ruled out, with a negative predictive value of 99.7% and sensitivity of 98.7% (95% confidence interval 99.2% to 99.9% and 96.3% to 99.6%, respectively), whereas 265 patients (12.6%) were ruled in, having a positive predictive value of 69.4% and specificity of 95.7% (95% confidence interval 63.6% to 74.7% and 94.7% to 96.5%, respectively). The remaining 783 patients (37.1%) were classified as having continued evaluations, with an acute myocardial infarction incidence of 5.6% (95% confidence interval 4.2% to 7.5%). The overall 30-day risk of death or postdischarge acute myocardial infarction was very low in the ruled-out patients but was incrementally increased in the other groups (rule-out 0.2%; continued evaluations 2.1%; rule-in 4.8%). Equivalent results were observed in the 0/2- to 3-hour analyses and when both algorithms were applied to the hs-cTnI ADVIA Centaur measurements. CONCLUSION:The European rapid rule-out/rule-in acute myocardial infarction algorithm hs-cTnI cut points can be harmonized with a demographically and risk-factor diverse US ED population.
Type
Conference
Subject
Humans
Myocardial Infarction
Troponin I
Electrocardiography
Patient Discharge
Sensitivity and Specificity
Follow-Up Studies
Prospective Studies
Predictive Value of Tests
Algorithms
Decision Support Techniques
Time Factors
Aged
Middle Aged
Emergency Service, Hospital
United States
Female
Male
Biomarkers
Permalink
https://hdl.handle.net/10161/25092
Published Version (Please cite this version)
10.1016/j.annemergmed.2019.12.008
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Scholars@Duke

Limkakeng

Alexander Tan Limkakeng Jr.

Professor of Surgery
My personal research interest is finding new ways to diagnose acute coronary syndrome. In particular, I am interested in novel biomarkers and precision medicine approaches to this problem. I also have an interest in sepsis and empirical bioethics. As Vice Chief of Research for the Duke Division of Emergency Medicine, I also work with researchers from many fields spanning global health, innovation, clinical trials, basic discovery, and translational research. The

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