Design and rationale of the HARTc 2.0 trial: a multicenter randomized controlled study on the impact of point-of-care high-sensitivity cardiac troponin-I testing in prehospital acute coronary syndrome triage on diagnosis and cost-effectiveness

Abstract

Introduction: Chest pain accounts for similar to 10% of emergency department visits, though most cases are not acute coronary syndrome (ACS), underscoring the need for effective prehospital triage. The HARTc 2.0 study evaluates the modified History, Electrocardiogram, Age, Risk Factors, and Troponin (HEART) score incorporating point-of-care (POC) high-sensitivity cardiac troponin-I (hs-cTnI) capillary fingerprick testing with sex-specific cut-offs to improve ACS risk stratification. The randomized controlled trial compares a prehospital triage strategy using this modified HEART score and a 0/2-hour POC hs-cTnI algorithm to standard care using HEAR score and in-hospital 0/1-hour hs-cTnT testing. Cost-effectiveness and diagnostic timing are also assessed. Methods and analysis: The HARTc 2.0 study consists of 4 prospective phases to improve prehospital risk stratification for patients with suspected ACS. Phase 0 investigates technical operability of the Siemens Atellica VTLi POC hs-cTnI device. Phase 1 verifies preanalytical and analytical performance. Phase 2 evaluates clinical comparability between modified HEART score (with POC hs-cTnI) and standard HEART score. Phase 3 is a multicenter randomized controlled trial assessing the impact of prehospital risk stratification-into low, intermediate, or high-risk for ACS-on clinical decision-making, time-to-diagnosis, and cost-effectiveness. Conclusion: This trial evaluates modified HEART score with POC hs-cTnI testing, incorporating sex-specific cut-offs, to improve prehospital ACS risk stratification. Phases 0 and 1 confirm the reliability of capillary whole blood POC hs-cTnI. Furthermore, the trial is a randomized trial which evaluates prehospital risk stratification for ACS using a 0/2-hour POC hs-cTnI algorithm on clinical decision-making, time-to-diagnosis, as well as its cost-effectiveness. Improved prehospital risk stratification for ACS aims to enhance triage accuracy, time-to-diagnosis and time-to-treatment, thereby reducing unnecessary hospital admissions and improve resource allocation in prehospital and emergency care. Trial registration: NL80873.000.22, NL9475 (registered in the Dutch Trial Register, the Netherlands).