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Single High-Sensitivity Cardiac Troponin I to Rule Out Acute Myocardial Infarction - 23/08/17

Doi : 10.1016/j.amjmed.2017.02.032 
Yader Sandoval, MD a, Stephen W. Smith, MD b, Sara A. Love, PhD c, d, Anne Sexter, MPH c, Karen Schulz, DC c, Fred S. Apple, PhD c, d,
a Division of Cardiology, Hennepin County Medical Center and Minneapolis Heart Institute, Abbott Northwestern Hospital, Minn 
b Department of Emergency Medicine, Hennepin County Medical Center and University of Minnesota, Minneapolis 
c Minneapolis Medical Research Foundation, Minn 
d Department of Laboratory Medicine and Pathology, Hennepin County Medical Center and University of Minnesota, Minneapolis 

Requests for reprints should be addressed to Fred S. Apple, PhD, Hennepin County Medical Center, Clinical Laboratories P4, 701 Park Avenue, Minneapolis, MN 55415.Hennepin County Medical CenterClinical Laboratories P4701 Park AvenueMinneapolisMN55415

Abstract

Background

This study examined the performance of single high-sensitivity cardiac troponin I (hs-cTnI) measurement strategies to rule out acute myocardial infarction.

Methods

This was a prospective, observational study of consecutive patients presenting to the emergency department (n = 1631) in whom cTnI measurements were obtained using an investigational hs-cTnI assay. The goals of the study were to determine 1) negative predictive value (NPV) and sensitivity for the diagnosis of acute myocardial infarction, type 1 myocardial infarction, and type 2 myocardial infarction; and 2) safety outcome of acute myocardial infarction or cardiac death at 30 days using hs-cTnI less than the limit of detection (LoD) (<1.9 ng/L) or the High-STEACS threshold (<5 ng/L) alone and in combination with normal electrocardiogram (ECG).

Results

Acute myocardial infarction occurred in 170 patients (10.4%), including 68 (4.2%) type 1 myocardial infarction and 102 (6.3%) type 2 myocardial infarction. For hs-cTnI<LoD (27%), the NPV and sensitivity for acute myocardial infarction were 99.6% (95% confidence interval 98.9%-100%) and 98.8 (97.2%-100%). For hs-cTnI<5 ng/L (50%), the NPV and sensitivity for acute myocardial infarction were 98.9% (98.2%-99.6%) and 94.7% (91.3%-98.1%). In combination with a normal ECG, 1) hs-cTnI<LoD had an NPV of 99.6% (98.9%-100%) and sensitivity of 99.4% (98.3%-100%); and 2) hs-cTnI<5 ng/L had an NPV of 99.5% (98.8%-100%) and sensitivity of 98.8% (97.2%-100%). The NPV and sensitivity for the safety outcome were excellent for hs-cTnI<LoD alone or in combination with a normal ECG, and for hs-cTnI<5 ng/L in combination with a normal ECG.

Conclusion

Strategies using a single hs-cTnI alone or in combination with a normal ECG allow the immediate identification of patients unlikely to have acute myocardial infarction and who are at very low risk for adverse events at 30 days.

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Keywords : Acute myocardial infarction, High-sensitivity cardiac troponin, Troponin


Plan


 Funding: The UTROPIA study (NCT02060760) is partially funded through a grant from 1) Abbott Diagnostics, who had no role in the design and conduction of the study; including data collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the final manuscript; and 2) the Minneapolis Medical Research Foundation.
 Conflict of Interest: SWS is a consultant for Alere and advisor for Roche Clinical Diagnostics. SAL is a research principal investigator through the Minneapolis Medical Research Foundation (MMRF), not salaried, for Biokit, Hytest Ltd, and Instrumentation Laboratory; and is on the editorial board of the Journal of Applied Laboratory Medicine. FSA is a consultant for Philips Healthcare Incubator and Metanomics Healthcare; is on the Board of Directors for HyTest Ltd; has received honoraria from Instrumentation Laboratory and Abbott POC; is a research principal investigator through the MMRF, not salaried, for Abbott Diagnostics, Roche Diagnostics, Siemens Healthcare, Alere, Ortho-Clinical Diagnostics, Nanomix, Becton Dickinson, and Singulex; and is Associate Editor for Clinical Chemistry.
 Authorship: All authors had access to the data and a role in writing the manuscript.


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Vol 130 - N° 9

P. 1076 - septembre 2017 Retour au numéro
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