1. Single High-Sensitivity Point-of-Care Whole-Blood Cardiac Troponin I Measurement to Rule Out Acute Myocardial Infarction at Low Risk
- Author
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Fred S. Apple, Stephen W. Smith, Jaimi H. Greenslade, Yader Sandoval, William Parsonage, Isuru Ranasinghe, Niranjan Gaikwad, Karen Schulz, Laura Stephensen, Christian W. Schmidt, Brynn Okeson, Louise Cullen, Emily Brownlee, Gavin Fincher, Emma Hall, Rebecca Hancock, Vinay Gangathimmaiah, Christian Hamilton-Craig, Andrew Hobbins-King, Gerben Keijzers, Maryam Khorramshahi Bayat, Ellyse McCormick, Ehsan Mahmoodi, Siegfried Perez, Andrew Staib, Anna Zournazi, and Martin Than
- Subjects
Troponin T ,Physiology (medical) ,Point-of-Care Systems ,Troponin I ,Australia ,Myocardial Infarction ,Humans ,Acute Coronary Syndrome ,Cardiology and Cardiovascular Medicine ,Emergency Service, Hospital ,Biomarkers - Abstract
Background: High-sensitivity cardiac troponin (hs-cTn) laboratory assays are used to rule out myocardial infarction (MI) on presentation, but prolonged result turnaround times can delay patient management. Our primary aim was to identify patients at low risk of index MI using a rapid point-of-care (POC) whole-blood hs-cTnI assay at presentation with potential early patient discharge. Methods: Consecutive patients presenting to the emergency department from 2 prospective observational studies with suspected acute coronary syndrome were enrolled. A POC hs-cTnI assay (Atellica VTLi) threshold using whole blood at presentation, which resulted in a negative predictive value of ≥99.5% and sensitivity of >99% for index MI, was derived (SEIGE [Safe Emergency Department Discharge Rate]) and validated with plasma (SAMIE [Suspected Acute Myocardial Infarction in Emergency]). Event adjudications were established with hs-cTnI assay results from routine clinical care. The primary outcome was MI at 30 days. Results: A total of 1086 patients (8.1% with MI) were enrolled in a US derivation cohort (SEIGE) and 1486 (5.5% MI) in an Australian validation cohort (SAMIE). A derivation whole-blood POC hs-cTnI concentration of Conclusions: A POC whole-blood hs-cTnI assay permits accessible, rapid, and safe exclusion of MI and may expedite discharge from the emergency department. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04772157. URL: https://www.australianclinicaltrials.gov.au/anzctr_feed/form ; Unique identifier: 12621000053820.
- Published
- 2022