Misdiagnosis of Myocardial Infarction Related to Limitations of the Current Regulatory Approach to Define Clinical Decision Values for Cardiac Troponin
| Autor: | Raphael Twerenbold, Amely Heinzelmann, Zoraida Moreno Weidmann, Katharina Rentsch, Petra Hillinger, Philipp Kreutzinger, Christian Mueller, Philip Haaf, Karin Wildi, Thomas Herrmann, Berit Nelles, Sophie Druey, Lian Krivoshei, Christian Puelacher, Michael Freese, Christiane Arnold, Tobias Reichlin, Claudia Stelzig, Nicolas Schaerli, Maria Rubini Gimenez, Stefan Osswald, Yunus Tanglay, Cedric Jaeger |
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| Rok vydání: | 2015 |
| Předmět: |
Male
Pathology International Cooperation Sistema cardiovascular -- Malalties Kaplan-Meier Estimate 030204 cardiovascular system & hematology 0302 clinical medicine Reference Values Troponin I Coronary Heart Disease Medicine Prospective Studies 030212 general & internal medicine Myocardial infarction Medical diagnosis Prospective cohort study health care economics and organizations Aged 80 and over Troponin T biology troponin Incidence Incidence (epidemiology) Middle Aged 3. Good health Survival Rate myocardial infarction Marcadors bioquímics ComputingMethodologies_DOCUMENTANDTEXTPROCESSING Cardiology Female Cardiology and Cardiovascular Medicine biological markers medicine.medical_specialty 03 medical and health sciences Sex Factors Physiology (medical) Internal medicine acute cardiac care Humans cardiovascular diseases Diagnostic Errors Survival rate Aged business.industry Myocardium Original Articles medicine.disease Troponin Infart de miocardi biology.protein business Biomarkers Follow-Up Studies |
| Zdroj: | Circulation |
| ISSN: | 1524-4539 0009-7322 |
| Popis: | Supplemental Digital Content is available in the text. Background— Misdiagnosis of acute myocardial infarction (AMI) may significantly harm patients and may result from inappropriate clinical decision values (CDVs) for cardiac troponin (cTn) owing to limitations in the current regulatory process. Methods and Results— In an international, prospective, multicenter study, we quantified the incidence of inconsistencies in the diagnosis of AMI using fully characterized and clinically available high-sensitivity (hs) cTn assays (hs-cTnI, Abbott; hs-cTnT, Roche) among 2300 consecutive patients with suspected AMI. We hypothesized that the approved CDVs for the 2 assays are not biologically equivalent and might therefore contribute to inconsistencies in the diagnosis of AMI. Findings were validated by use of sex-specific CDVs and parallel measurements of other hs-cTnI assays. AMI was the adjudicated diagnosis in 473 patients (21%). Among these, 86 patients (18.2%) had inconsistent diagnoses when the approved uniform CDV was used. When sex-specific CDVs were used, 14.1% of female and 22.7% of male AMI patients had inconsistent diagnoses. Using biologically equivalent CDV reduced inconsistencies to 10% (P |
| Databáze: | OpenAIRE |
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