Observational studyJournal of the American Heart Association2025
Possible Misdiagnosis of Myocardial Infarction Using Regulatory-Approved and Close-to-Bioequivalent Upper Limits of Normal for Cardiac Troponin.
Observational study in Journal of the American Heart Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00470587 (Advantageous Predictors of Acute Coronary Syndromes Evaluation), which is not on this map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Advantageous Predictors of Acute Coronary Syndromes Evaluation (APACE) Study
Who cites it
4 citing papers in PubMed.
- Association between miRNAs and DEFA4 in coronary artery disease.Molecular biology reports · 2026Article
- A 5-hydroxymethylcytosine-based noninvasive model for acute myocardial infarction in type 2 diabetes: implications in cardiovascular outcomes from a 5-year median follow-up study.Cardiovascular diabetology · 2026Article
- Succinylation-annotated genes in AMI: multi-omics and single-cell prioritization of ASGR2 and NPL.Frontiers in cardiovascular medicine · 2026Article
- Elevated Cardiac Troponin in Non-Cardiac Conditions Unrelated to Acute Myocardial Infarction.International journal of molecular sciences · 2025Review
Corrections and comments
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Authors and funding
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPossible misdiagnosis of acute myocardial infarction (AMI) may occur due to inappropriate upper limit of normal (ULN) for cardiac troponin and has the potential to harm patients. In this observational international multicenter study, we aimed to assess to what extent the novel hs-cTn-assays are affected.
methodsA total of 6646 patients presenting with suspected AMI to the emergency department were enrolled. All level pairs (n=18 732) of 4 widely used high-sensitivity cardiac troponin T/I (hs-cTnT/I) assays using (1) the regulatory-approved uniform and sex-specific clinical ULN and (2) mathematically derived close-to-bioequivalent ULNs were assessed. The primary outcome was the quantification of the incidence of inconsistencies in the diagnosis of AMI. Inconsistency was defined as hs-cTnT/I concentration above the recommended ULN in one but not the other assay: for example, hs-cTnT-Elecsys+/hs-cTnI-Architect- or hs-cTnT-Elecsys-/hs-cTnI-Architect+.
resultsAMI was the adjudicated diagnosis in 1422 patients (21.4%). When the regulatory-approved uniform ULN was used, the rate of inconsistent AMI diagnoses was 17.6% (Elecsys/Architect), 18.8% (Elecsys/Centaur), 14.2% (Elecsys/Access), 4.9% (Architect/Centaur), 8.3% (Architect/Access), and 7.4% (Access/Centaur), respectively. Overall, diagnostic mismatches were not decreased, but in fact increased using regulatory-approved sex-specific ULNs. In women as compared with men, they were 23.8% versus 17.6% (Elecsys/Architect), 30.1% versus 19.1% (Elecsys/Centaur), 23.2% versus 15% (Elecsys/Access), 7.2% versus 4.5% (Architect/Centaur), 8.3% versus 8.7% (Architect/Access) and 7.8% versus 8.2% (Access/Centaur), respectively. Using close-to-bioequivalent ULNs reduced inconsistencies by 15% to 20% (
conclusionsCurrent regulatory-approved uniform and sex-specific ULNs for hs-cTnT/I result in discordances in binary assay results, possibly impacting the diagnosis of AMI. A regulatory process that defines bioequivalent ULNs could reduce inconsistencies significantly. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00470587.
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