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Gallacher PJ, Miller-Hodges E, Shah AS, et al. Use of High-Sensitivity Cardiac Troponin in Patients With Kidney Impairment: A Randomized Clinical Trial. JAMA Intern Med. Published online June 07, 2021. doi:10.1001/jamainternmed.2021.1184
High-sensitivity cardiac troponin (hs-cTn) assays have improved the diagnosis of myocardial infarction in patients with healthy kidney function and are now widely used in clinical practice.1 However, in patients with kidney impairment, long-term elevations in troponin levels are common, and interpretation can be more challenging.2 As such, the effect of implementing hs-cTn testing on the diagnosis and outcomes of patients with kidney impairment is uncertain.
High-Sensitivity Troponin in the Evaluation of Patients With Acute Coronary Syndrome (High-STEACS) was a stepped-wedge, cluster-randomized clinical trial that evaluated the use of a hs-cTnI assay in consecutive patients with suspected acute coronary syndrome across 10 hospitals (NCT01852123) (Supplement 1; eAppendix in Supplement 2).3 The trial was conducted in accordance with the Declaration of Helsinki and with the approval of the Scotland Research Ethics Committee, the Public Benefit and Privacy Panel for Health and Social Care, and each National Health Service Health Board. As randomization was at the hospital level, individual patient consent was not sought. Throughout the trial, cTnI was measured using contemporary and high-sensitivity assays (ARCHITECTSTAT; Abbott Laboratories). Before use, results from the hs-cTnI assay were suppressed, and the contemporary assay (single threshold based on the coefficient of variation) guided care. Sites were then randomly assigned to early or late use of hs-cTnI testing, for which results from the contemporary assay were suppressed and care was guided by the hs-cTnI assay with sex-specific 99th percentile diagnostic thresholds.
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