0/2 h-Algorithm for Rapid Triage of Suspected Myocardial Infarction Using a Novel High-Sensitivity Cardiac Troponin I Assay

Background We aimed to derive and validate a 0/2 h-algorithm using the new high-sensitivity cardiac troponin I (hs-cTnI)-VITROS assay (VITROS® Immunodiagnostic Products hs-Troponin I Reagent Pack, Ortho Clinical Diagnostics) for rapid rule-out/in of non-ST-segment elevation myocardial infarction (NSTEMI). Methods The final diagnosis was centrally adjudicated by 2 independent cardiologists according to the fourth universal definition of myocardial infarction (MI) among 1888 patients presenting to the emergency department with acute chest pain. hs-cTnI-VITROS concentrations were measured at presentation and at 2 h in a blinded fashion. The optimal assay-specific thresholds for the hs-cTnI-VITROS 0/2 h-algorithm were derived in a randomly selected 70% of the cohort and validated in the remaining 30%. Results NSTEMI was the final diagnosis in 216/1322 (16.3%) patients of the derivation cohort. Rule-out was defined as baseline hs-cTnI concentrations of 3 h or a baseline hs-cTnI concentration of Conclusion hs-cTnI-VITROS concentrations at presentation combined with absolute changes within the first 2 h allowed safe rule-out and accurate rule-in of NSTEMI in two-thirds of unselected patients presenting with acute chest pain to the emergency department. Trial registration www.clinicaltrials.gov: NCT0047058