Acute rule-out of non-ST-segment elevation acute coronary syndrome in the (pre)hospital setting by HEART score assessment and a single point-of-care troponin: rationale and design of the ARTICA randomised trial

BMJ Open. 2020 Feb 17;10(2):e034403. doi: 10.1136/bmjopen-2019-034403.

Abstract

Introduction: Because of the lack of prehospital protocols to rule out a non-ST-segment elevation acute coronary syndrome (NSTE-ACS), patients with chest pain are often transferred to the emergency department (ED) for thorough evaluation. However, in low-risk patients, an ACS is rarely found, resulting in unnecessary healthcare consumption. Using the HEART (History, ECG, Age, Risk factors and Troponin) score, low-risk patients are easily identified. When a point-of-care (POC) troponin measurement is included in the HEART score, an ACS can adequately be ruled out in low-risk patients in the prehospital setting. However, it remains unclear whether a prehospital rule-out strategy using the HEART score and a POC troponin measurement in patients with suspected NSTE-ACS is cost-effective.

Methods and analysis: The ARTICA trial is a randomised trial in which the primary objective is to investigate the cost-effectiveness after 30 days of an early rule-out strategy for low-risk patients suspected of a NSTE-ACS, using a modified HEART score including a POC troponin T measurement. Patients are included by ambulance paramedics and 1:1 randomised for (1) presentation at the ED (control group) or (2) POC troponin T measurement (intervention group) and transfer of the care to the general practitioner in case of a low troponin T value. In total, 866 patients will be included. Follow-up will be performed after 30 days, 6 months and 12 months.

Ethics and dissemination: This trial has been accepted by the Medical Research Ethics Committee region Arnhem-Nijmegen. The results of this trial will be disseminated in one main paper and in additional papers with subgroup analyses.

Trial registration number: Netherlands Trial Register (NL7148).

Keywords: acute coronary syndrome; ambulance; cost-effectiveness; modified HEART score; point-of-care troponin; pre-hospital.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Coronary Syndrome* / diagnosis
  • Biomarkers
  • Chest Pain
  • Electrocardiography
  • Hospitals
  • Humans
  • Netherlands
  • Point-of-Care Systems*
  • Prospective Studies
  • Randomized Controlled Trials as Topic
  • Troponin T
  • Troponin*

Substances

  • Biomarkers
  • Troponin
  • Troponin T

Associated data

  • NTR/NL7148