TY - JOUR
T1 - A Reduction in Time with Electronic Monitoring In Stroke (ARTEMIS)
T2 - study protocol for a randomised multicentre trial
AU - Koster, Gaia T
AU - Nguyen, T Truc My
AU - Groot, Adrien E D
AU - Coutinho, Jonathan M
AU - Bosch, Jan
AU - den Hertog, Heleen M
AU - van Walderveen, Marianne A A
AU - Algra, Ale
AU - Wermer, Marieke J H
AU - Roos, Yvo B
AU - Kruyt, Nyika D
N1 - Publisher Copyright:
© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
PY - 2018/6/27
Y1 - 2018/6/27
N2 - INTRODUCTION: Time is the most crucial factor limiting efficacy of intravenous thrombolysis (IVT) and intra-arterial thrombectomy (IAT). The delay between alarming the Emergency Medical Services (EMS) dispatch office and IVT/IAT initiation, that is, the 'total system delay' (TSD), depends on logistics and team effort. A promising method to reduce TSD is real-time audio-visual feedback to caregivers involved. With 'A Reduction in Time with Electronic Monitoring in Stroke' (ARTEMIS), we aim to investigate the effect of real-time audio-visual feedback on actual TSD to IVT/IAT to caregivers.METHODS AND ANALYSIS: ARTEMIS is a multiregional, multicentre, randomised open end-point trial including patients ≥18 years considered IVT/IAT-eligible by the EMS dispatch office or on-site EMS personnel. Patients are electronically tracked and randomised for real-time audio-visual feedback on TSD to caregivers via premounted handhelds and tablets throughout the TSD trajectory. Primary outcome is TSD to IVT/IAT. Secondary outcomes comprise proportion of IVT/IAT-treated patients, symptomatic intracerebral haemorrhage, IVT/IAT-treated stroke mimics, clinical outcome after three months and cost-effectiveness. Separate analyses for IAT-patients with or without prior IVT, within or out of office hours and EMS region will be performed. With 75 IAT-patients and 225 IVT-patients in each arm, we will be able to demonstrate a 20 min difference in TSD to IAT and a 10 min difference in TSD to IVT (p=0.05 and power=0.8).ETHICS AND DISSEMINATION: Study findings will be disseminated through peer-reviewed journals and (inter)national conference presentations.TRIAL REGISTRATION NUMBER: NCT02808806; Pre-results.
AB - INTRODUCTION: Time is the most crucial factor limiting efficacy of intravenous thrombolysis (IVT) and intra-arterial thrombectomy (IAT). The delay between alarming the Emergency Medical Services (EMS) dispatch office and IVT/IAT initiation, that is, the 'total system delay' (TSD), depends on logistics and team effort. A promising method to reduce TSD is real-time audio-visual feedback to caregivers involved. With 'A Reduction in Time with Electronic Monitoring in Stroke' (ARTEMIS), we aim to investigate the effect of real-time audio-visual feedback on actual TSD to IVT/IAT to caregivers.METHODS AND ANALYSIS: ARTEMIS is a multiregional, multicentre, randomised open end-point trial including patients ≥18 years considered IVT/IAT-eligible by the EMS dispatch office or on-site EMS personnel. Patients are electronically tracked and randomised for real-time audio-visual feedback on TSD to caregivers via premounted handhelds and tablets throughout the TSD trajectory. Primary outcome is TSD to IVT/IAT. Secondary outcomes comprise proportion of IVT/IAT-treated patients, symptomatic intracerebral haemorrhage, IVT/IAT-treated stroke mimics, clinical outcome after three months and cost-effectiveness. Separate analyses for IAT-patients with or without prior IVT, within or out of office hours and EMS region will be performed. With 75 IAT-patients and 225 IVT-patients in each arm, we will be able to demonstrate a 20 min difference in TSD to IAT and a 10 min difference in TSD to IVT (p=0.05 and power=0.8).ETHICS AND DISSEMINATION: Study findings will be disseminated through peer-reviewed journals and (inter)national conference presentations.TRIAL REGISTRATION NUMBER: NCT02808806; Pre-results.
KW - acute ischemic stroke
KW - intra-arterial thrombectomy
KW - intravenous thrombolysis
KW - time to treatment
KW - total system delay
KW - treatment delay
U2 - 10.1136/bmjopen-2017-020844
DO - 10.1136/bmjopen-2017-020844
M3 - Article
C2 - 29950465
SN - 2044-6055
VL - 8
JO - BMJ Open
JF - BMJ Open
IS - 6
M1 - e020844
ER -