Abstract
INTRODUCTION: Ischaemic heart disease is the single most common cause of death worldwide. Traditionally, distinguishing patients with cardiac ischaemia from patients with less alarming disease, in prehospital triage of chest pain, is challenging for both general practitioners and ambulance paramedics. Less than 20% of patients with chest pain, transferred to the emergency department (ED), have an acute coronary syndrome (ACS) and the transportation and analysis at the ED of non-ACS patients result in substantial healthcare costs and a great patient burden. Advanced risk stratification, with the help of cardiac troponin measurements, seems crucial to improve prehospital diagnostic accuracy. METHODS AND ANALYSIS: The URGENT 2.0 trial is a randomised controlled trial in which the primary objective is to reduce the referral of non-cardiac chest pain (NCCP) patients, using a modified HEART score including a high-sensitivity capillary point-of-care high-sensitivity cardiac troponin I measurement. Patients are included by ambulance paramedics and 1:1 randomised for (1) regular care (control group) or (2) modified HEART score analysis (intervention group) and non-referral in case of a low modified HEART score (0-3). In total, 852 patients will be included. Follow-up will be performed at 30 days, 6 months and 12 months. Both referral rates of NCCP patients and the occurrence of major adverse cardiac events are defined as primary outcome measures. ETHICS AND DISSEMINATION: The medical ethics committee Zuyderland-Zuyd Hogeschool (Netherlands) has approved this trial (reference numbers NL71820.096.19 and METCZ20190139). Written informed consent will be obtained from all participating patients. The results of this trial will be disseminated in one main paper and in additional papers with subgroup analyses. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04904107.