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Multicenter Study
. 2019 Nov;65(11):1437-1447.
doi: 10.1373/clinchem.2019.305193. Epub 2019 Sep 30.

Two-Hour Algorithm for Rapid Triage of Suspected Acute Myocardial Infarction Using a High-Sensitivity Cardiac Troponin I Assay

Thomas Nestelberger  1   2 , Jasper Boeddinghaus  1   2   3 , Jaimi Greenslade  4   5   6 , William A Parsonage  4   5   6 , Martin Than  7 , Desiree Wussler  1   2   3 , Pedro Lopez-Ayala  1   2 , Tobias Zimmermann  1   2 , Mario Meier  1   2 , Valentina Troester  1   2 , Patrick Badertscher  1   2   8 , Luca Koechlin  1   2   9 , Karin Wildi  1   3   10 , Mahnoor Anwar  1   2 , Michael Freese  1   2 , Dagmar I Keller  11 , Tobias Reichlin  1   2   12 , Raphael Twerenbold  1   2 , Louise Cullen  2   4   5   6 , Christian Mueller  13   2 ; APACE and ADAPT Investigators
Affiliations
Multicenter Study

Two-Hour Algorithm for Rapid Triage of Suspected Acute Myocardial Infarction Using a High-Sensitivity Cardiac Troponin I Assay

Thomas Nestelberger et al. Clin Chem. 2019 Nov.

Abstract

Background: We aimed to derive and externally validate a 0/2-h algorithm using the high-sensitivity cardiac troponin I (hs-cTnI)-Access assay.

Methods: We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI) in 2 prospective diagnostic studies using central adjudication. Two independent cardiologists adjudicated the final diagnosis, including all available medical information including cardiac imaging. hs-cTnI-Access concentrations were measured at presentation and after 2 h in a blinded fashion.

Results: AMI was the adjudicated final diagnosis in 164 of 1131 (14.5%) patients in the derivation cohort. Rule-out by the hs-cTnI-Access 0/2-h algorithm was defined as 0-h hs-cTnI-Access concentration <4 ng/L in patients with an onset of chest pain >3 h (direct rule-out) or a 0-h hs-cTnI-Access concentration <5 ng/L and an absolute change within 2 h <5 ng/L in all other patients. Derived thresholds for rule-in were a 0-h hs-cTnI-Access concentration ≥50 ng/L (direct rule-in) or an absolute change within 2 h ≥20 ng/L. In the derivation cohort, these cutoffs ruled out 55% of patients with a negative predictive value (NPV) of 99.8% (95% CI, 99.3-100) and sensitivity of 99.4% (95% CI, 96.5-99.9), and ruled in 30% of patients with a positive predictive value (PPV) of 73% (95% CI, 66.1-79). In the validation cohort, AMI was the adjudicated final diagnosis in 88 of 1280 (6.9%) patients. These cutoffs ruled out 77.9% of patients with an NPV of 99.8% (95% CI, 99.3-100) and sensitivity of 97.7% (95% CI, 92.0-99.7), and ruled in 5.8% of patients with a PPV of 77% (95% CI, 65.8-86) in the validation cohort.

Conclusions: Safety and efficacy of the l hs-cTnI-Access 0/2-h algorithm for triage toward rule-out or rule-in of AMI are very high.

Trial registration: APACE, NCT00470587; ADAPT, ACTRN1261100106994; IMPACT, ACTRN12611000206921.

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