Coronary disease & ACS

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

Am Heart JPublished Design and rationale of a multicentre randomised controlled trial

Study context

Population
Patients with suspected acute coronary syndrome (ACS) in prehospital triage
Planned comparison
Modified HEART score vs Standard care
Primary endpoint
Impact of prehospital risk stratification (low, intermediate or high risk for ACS) on clinical decision-making, time-to-diagnosis and cost-effectiveness
Methodological details4 prospective phases, Phase 0: technical operability of Siemens Atellica VTLi point-of-care (POC) high-sensitivity cardiac troponin-I (hs-cTnI) device; Phase 1: preanalytical and analytical performance; Phase 2: clinical comparability of modified vs standard HEART score; Phase 3: multicentre RCT
  • 4 prospective phases
  • Phase 0: technical operability of Siemens Atellica VTLi POC hs-cTnI device; Phase 1: preanalytical and analytical performance; Phase 2: clinical comparability of modified vs standard HEART score; Phase 3: multicentre RCT

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

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. Am Heart J. Published 16 July 2025. doi:10.1016/j.ahj.2025.07.009

Summarised from the published abstract; every number is checked against it

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