Rapid use of high-sensitive cardiac troponin I for ruling-in and ruling-out of acute myocardial infarction (RACING-MI): study protocol

Abstract

IntroductionThe European Society of Cardiology has suggested an accelerated algorithm for ruling-in and ruling-out myocardial infarction (MI) with high-sensitive cardiac troponin (hs-cTn) measured at admission (0 hour) and after 1 hour (1 hour) as an alternative to standard measurements at 0 hour and 3 hours. However, the 0 hour/1 hour algorithm has only been tested in a limited amount of patient cohorts and not for all hs-cTn assays. Moreover, it is unknown if MI can be ruled-out faster than 1 hour. In this single-centre, clinical trial, we will investigate whether MI safely can be ruled-in or ruled-out after 30 min and 1 hour.Methods and analysisPatients with chest pain suggestive of MI admitted to the emergency department will be subjected to hs-cTn measurements at the following time points: 0 hour, 30 min, 1 hour and 3 hours. Chest pain characteristics will be recorded. In total, 1000 patients with all four blood samples will be included. The diagnostic algorithms will be derived based on the first 500 patients and validated in the subsequent 500 patients. The primary endpoint is the negative predictive value of the 0 hour/30 min and the 0 hour/1 hour algorithms. Secondary endpoints include positive predictive value, sensitivity and specificity. Results will be compared with the standard 0 hour/3 hour algorithm.Ethics and disseminationOral and written informed consent will be obtained from all patients. The trial is approved by The Regional Committee on Health Research Ethics and the Danish Data Protection Agency. Data will be disseminated and submitted to peer-reviewed scientific journals and meetings irrespective of study outcome.Trial registration numberNCT03634384

Revisiting the Biological Variability of Cardiac Troponin: Implications for Clinical Practice

“…Further prospective studies are required to incorporate diagnostic protocols into routine clinical practice to facilitate optimal use of hs-cTn assays. 99 Such studies may also help to confirm diagnostic thresholds for significant change according to other factors such as gender, age group, time of symptom onset and comorbidities such as chronic cardiac or renal failure. 100 For example, a recent study in individuals with chronic kidney disease proposed algorithms where the relative change cut-off for hs-cTnI was 280% and for hs-cTnT was 250%, which are vastly different from the 20% cut-off defined by international recommendations.…”

Diagnostic Impact of Hs-CRP and IL-6 for Acute Coronary Syndrome in Patients Admitted to the ED with Chest Pain: Added Value to the HEART Score?

“…This study was a post-hoc analysis based on a single-center clinical cohort study, the Rapid Use of High-Sensitive Cardiac Troponin I for Ruling-in and Ruling-out of Acute Myocardial Infarction: the RACING-MI cohort study. 22 , 23 The RACING-MI cohort study was conducted between November 2016 and February 2019 and included patients with chest pain indicative of ACS who were admitted to the ED at a Danish regional hospital. The study design and methods have been previously described and published.…”

“…The study design and methods have been previously described and published. 22 The RACING-MI protocol was approved by The Regional Committee on Health Research Ethics (no.1-10-72-213-16). The investigation conforms with the principles outlined in the Declaration of Helsinki and the Danish Health Act.…”

“…The study design and methods have been previously described and published. 22 The RACING-MI protocol was approved by The Regional Committee on Health Research Ethics (no. 1-10-72-213-16).…”