0/1h-algorithm using a new high-sensitivity cardiac troponin I assay for early diagnosis of myocardial infarction

Abstract Background The clinical performance of the novel high-sensitivity cardiac troponin I EXL (hs-cTnI-EXL) assay is unknown so far. Purpose We aimed to validate hs-cTnI-EXL and derive an hs-cTnI-EXL-specific 0/1h-algorithm for early diagnosis myocardial infarction (MI). Methods This multicenter study included patients presenting emergency department with symptoms suggestive infarction. Central adjudication final diagnoses was performed by two independent cardiologists using all information including imaging twice: first, serial hs-cTnI-Architect (primary analysis) second, hs-cTnT-Elecsys (secondary concentrations in addition those clinically used (hs)-cTn. Hs-cTnI-EXL measured at presentation 1h. primary objective directly compare diagnostic accuracy quantified area under receiver-operating-characteristic curve (AUC) hs-cTnI-EXL, hs-cTnT-Elecsys. Secondary objectives derivation validation hs-cTnI- EXL-specific 0/1h-algorithm. Results MI adjudicated 204/1454 (14%) patients. At presentation, AUC 0.94 (95% CI, 0.93–0.96), being comparable (0.95; 95% 0.93–0.96) (0.93; 0.91–0.95; Figure 1). In cohort (n=813), optimal hs-cTnI-EXL-0/1h-algorithm rule-out <9ng/L if onset chest pain >3h or & 0h-1h-change <5ng/L, rule-in ≥160ng/L ≥100ng/L. (n=345), this also well: 56% patients, negative predictive value 99.5% 97.1–99.9), sensitivity 97.8% 88.7–99.6), 9% positive 83.3% 66.4–92.7), specificity 98.3% 96.1–99.3; 2). analyses confirmed findings measurements Conclusions has currently best-validated hs-cTnT/I assays. Funding Acknowledgement Type funding sources: Foundation. Main source(s): Swiss National Foundation, Heart Foundation