Prospective validation of a 1-hour algorithm to rule-out and rule-in acute myocardial infarction using a high-sensitivity cardiac troponin T assay.

Abstract

BACKGROUND:

We aimed to prospectively validate a novel 1-hour algorithm using high-sensitivity cardiac troponin T measurement for early rule-out and rule-in of acute myocardial infarction (MI).

METHODS:

In a multicentre study, we enrolled 1320 patients presenting to the emergency department with suspected acute MI. The high-sensitivity cardiac troponin T 1-hour algorithm, incorporating baseline values as well as absolute changes within the first hour, was validated against the final diagnosis. The final diagnosis was then adjudicated by 2 independent cardiologists using all available information, including coronary angiography, echocardiography, follow-up data and serial measurements of high-sensitivity cardiac troponin T levels.

RESULTS:

Acute MI was the final diagnosis in 17.3% of patients. With application of the high-sensitivity cardiac troponin T 1-hour algorithm, 786 (59.5%) patients were classified as "rule-out," 216 (16.4%) were classified as "rule-in" and 318 (24.1%) were classified to the "observational zone." The sensitivity and the negative predictive value for acute MI in the rule-out zone were 99.6% (95% confidence interval [CI] 97.6%-99.9%) and 99.9% (95% CI 99.3%-100%), respectively. The specificity and the positive predictive value for acute MI in the rule-in zone were 95.7% (95% CI 94.3%-96.8%) and 78.2% (95% CI 72.1%-83.6%), respectively. The 1-hour algorithm provided higher negative and positive predictive values than the standard interpretation of highsensitivity cardiac troponin T using a single cut-off level (both p < 0.05). Cumulative 30-day mortality was 0.0%, 1.6% and 1.9% in patients classified in the rule-out, observational and rule-in groups, respectively (p = 0.001).

INTERPRETATION:

This rapid strategy incorporating high-sensitivity cardiac troponin T baseline values and absolute changes within the first hour substantially accelerated the management of suspected acute MI by allowing safe rule-out as well as accurate rule-in of acute MI in 3 out of 4 patients.

TRIAL REGISTRATION:

ClinicalTrials.gov, NCT00470587.

• Authors: Tobias Reichlin, Raphael Twerenbold, Karin Wildi, Maria Rubini Gimenez, Nathalie Bergsma, Philip Haaf, Sophie Druey, Christian Puelacher, Berit Moehring, Michael Freese, Claudia Stelzig, Lian Krivoshei, Petra Hillinger, Cedric Jäger, Thomas Herrmann, Philip Kreutzinger, Milos Radosavac, Zoraida Moreno Weidmann, Kateryna Pershyna, Ursina Honegger, Max Wagener, Thierry Vuillomenet, Isabel Campodarve, Roland Bingisser, Òscar Miró, Katharina Rentsch, Stefano Bassetti, Stefan Osswald, Christian Mueller
• Journal: CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne (CMAJ) Vol. 187 Issue 8 Pg. E243-E252 (May 19 2015) ISSN: 1488-2329 [Electronic] Canada
• PMID: 25869867 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't, Validation Study)
• Copyright: © 2015 Canadian Medical Association or its licensors.

Chemical References

• Biomarkers
• Troponin T

Topics

• Aged
• Aged, 80 and over
• Algorithms
• Biomarkers (blood)
• Decision Support Techniques
• Electrocardiography
• Female
• Humans
• Male
• Middle Aged
• Myocardial Infarction (blood, diagnosis)
• Prospective Studies
• Troponin T (blood)