A multicentre, randomized, controlled open-label trial to compare an Accelerated Rule-Out protocol using combined prehospital copeptin and in-hospital high sensitive troponin with standard rule-out in patients suspected of acute Myocardial Infarction - The AROMI trial

Abstract

Background: Suspicion of acute myocardial infarction (AMI) is among the most common reasons for admission to hospital in Denmark. Owing to this suspicion, an estimated 50,000 patients are admitted every year. Only 15-20% are finally diagnosed with AMI, whereas 40% are discharged after rule-out of AMI and without initiation of any treatment or need for further admission. In patients discharged after rule-out, the current diagnostic protocol, using consecutive troponin measurements, results in an average length of stay (LOS) of 8-12 h. This leads to overcrowding in both the emergency departments and coronary care units. Measuring copeptin and high-sensitivity cardiac troponin (hs-cTn) upon hospital arrival has shown potential for early rule-out of AMI. However, the diagnostic performance may be improved by accelerating the copeptin measurement of blood sampled already in the pre-hospital phase. Additional evidence on LOS reduction and safety of the rule-out strategy in a large cohort of all-comers is needed. Methods/design: The rule-out potential is being evaluated in a randomized controlled trial including 4800 patients admitted to hospital for suspicion of AMI. Patients are randomized to either standard rule-out (consecutive troponin measurements) or accelerated rule-out (copeptin measured in a blood sample acquired before hospital admission, combined with troponin measured in the first blood sample upon admission). Discussion: Sampling blood for copeptin analysis already in the pre-hospital phase and combining this with a later hs-cTn measurement may be the optimal timing for achieving the best diagnostic performance in an AMI rule-out protocol/strategy. Moreover, we are directly comparing pre-hospital and in-hospital blood sample results to address this issue of timing, and we also are comparing single-marker strategies with dual-marker strategies. If the combination of copeptin and hs-cTn is confirmed to rule out AMI safely, implementation of this fast rule-out protocol could optimize patient flow, reduce health care expenses and enable allocation of resources to patients with confirmed illness. In future, when point-of-care analyses of copeptin and hs-cTn are available, hospitalization of the large proportion of patients with symptoms raising suspicion of AMI could potentially be avoided. Trial registration: ClinicalTrials.gov, NCT02666326. Registered on January 24, 2016.