American heart journal, 15 3 2025, Pages S0002-8703(25)00218-2 Design and rationale of the HARTc 2.0 trial: a multicentre randomized controlled study on the impact of point-of-care hs-cTnI testing in prehospital ACS triage on diagnosis and cost-effectiveness. van der Lande ACMH, Diederiks NM, de Koning ER, Bosch J, Romijn FPHTM, van der Loo WPM, van den Akker-van Marle ME, Dehnavi RA, Tietge WJ, Mertens BJA, Jukema JW, Cobbaert CM, Schalij MJ, Boogers MJ
Introduction
Chest pain accounts for ∼10% of emergency department visits, though most cases are not ACS, underscoring the need for effective prehospital triage. The HARTc 2.0 study evaluates the modified 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 (RCT) 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 point-of-care (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 multicentre RCT 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.
