A Reduction in Time With Electronic Monitoring In Stroke (ARTEMIS)

September 28, 2020 updated by: NyikaKruyt, Leiden University

A Reduction in Time With Electronic Monitoring In Stroke (ARTEMIS) Trial

The purpose of the ARTEMIS trial is to investigate if real-time feedback to caregivers reduces the time between patient's first medical contact and start of intravenous thrombolysis and/or intraarterial thrombectomy in patients with acute ischemic stroke.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Background

For the clinical benefit of intravenous thrombolysis (IVT) and intra-arterial thrombectomy (IAT) time is the most crucial factor. Reducing the time between stroke onset and treatment is therefore a major goal in acute stroke care. The delay from first moment the Emergency Medical Services (EMS) dispatch office is alarmed and initiation of treatment (IVT and/or IAT), i.e. 'total system delay' (TSD), depends greatly on logistics and collaboration between various caregivers in this trajectory. A promising method to improve workflow and thereby aiming to reduce TSD is to provide real-time audio-visual feedback to caregivers.

Methods

The A Reduction in Time with Electronic Monitoring In Stroke (ARTEMIS) trial is a multiregional, multicenter, prospective randomized open end-point trial to investigate the intervention of real-time audio-visual feedback to caregivers reduces TSD to IVT/IAT.

The intervention compromises real-time audio-visual feedback to caregivers on actual treatment delay for each individual patient. Randomization of real-time audio-visual feedback will be automatically generated per patient.

Study procedures

Patients will receive a unique wristband emitting a low-voltage Bluetooth signal (activated automatically after being opened by EMS personnel at the time of ambulance dispatch), which will be automatically picked up by handhelds in the ambulance and by pre-mounted in-hospital tablets en route to treatment with IVT and/or IAT.

Real-time audio-visual feedback will be delivered through handhelds and tablets en route from ambulance to initiation of IVT/IAT. Real-time visual feedback on actual treatment delays for the patient caregivers are transferring will be shown. Also, a color code (green, orange or red) will provide an easy-view visualization on whether or not preset median time delays between locations are exceeded. Additionally, on preset locations, such as the Emergency room (ER), computed tomography (CT) room and angio suites, auditory signals indicating the elapsed time will be installed.

TSD to IVT/IAT starts at the moment the dispatch office issues an ambulance for a patient that is potentially eligible for IVT/IAT. TSD ends at the moment IVT/IAT is initiated. For TSD to IVT this will be the moment the bolus of intravenous alteplase is administered, whereas the endpoint for TSD to IAT will be puncture of the groin and the last angio-run. These endpoints will be registered automatically once a fixed real-life push button in the CT-room/neuro-care unit or in the angio suite is pushed. All recordings on the patient tracking are automatically stored in a protected cloud.

Other study parameters collected include parameters necessary to perform cost effective analysis, and baseline characteristics such as patient parameters from ambulance, medical history, physical and additional test results and interventional features performed as part of standard care.

After treatment, during the first 24-48 hours of admission to the hospital, patients will be informed and a deferred consent will signed by the patient or legal representative. In addition, consent for the collection of clinical data and clinical outcome (modified Rankin Score (mRS)) assessment after three months will be collected. Clinical data will be collected and documented anonymously from the Electronic Patient Recording. Clinical outcome will be evaluated through a standardized and validated telephone interview, assessed by an observer blinded to treatment allocation.

Patients are allowed to refuse the wristband application without any consequences. Subjects can leave the study at any time for any reason if they wish to do so without any consequences.

Statistical Analysis

For the primary analysis and all secondary analyses involving endpoints with time intervals, the difference in time delays between calendar weeks with and without intervention will be calculated with corresponding 95% confidence intervals. The investigators will perform subgroup analysis for IAT patients with- or without prior IVT, and for patients within- and out of office hours. Subsequently the investigators will use linear regression analysis to adjust for EMS region and for location of treatment as this is expected to affect TSD to IVT/IAT. If required we will adjust for differences in EMS response and transfer times due to geographically different locations of stroke. Through additional regression analysis we will assess if there is an effect of time on TSD and whether such an effect is group dependent.

The total number of times the ambulance drives to a patient for suspected acute stroke will be used to calculate the proportion of patients with a discharge diagnosis of stroke and the total number of IVT/IAT treated patients will be used to calculate IVT/IAT rates during treatment or control weeks.

Exploratory analysis will be performed to relate TSD to clinical outcome in each group.

Sample size estimates

Sample size calculation is based on the hypothesis of an at least 20-minute reduction of TSD to IAT and an at least 10 minute reduction of TSD to IVT. The investigators think these reductions are feasible based on data from MR CLEAN (n=500) in which the standard deviation (SD) of TSD to IAT was 40 minutes, and of TSD for IVT SD was 35 minutes.

During a run-in phase the investigators will collect additional data on treatment delays to adjust the sample size calculation if appropriate. For now the investigators will use (unpublished) data from the "MR CLEAN" trial. In the "MR CLEAN" trial (n=500), the mean TSD to IAT in 233 patients was 256 minutes (SD: 40 minutes). To detect a 20-minute difference with a p-value of 0.05, and a power of 0.8 the investigators will need 63 patients in each arm. To increase power, the investigators will aim at including 75 patients with IAT in each arm.

For the co-primary outcome, the TSD to IVT, in the "MR CLEAN" trial the mean TSD for IVT was 90 minutes (SD: 35 minutes). To detect a 10-minute difference with a p-value of 0.05, and a power of 0.8 the investigators will need 193 IVT treated patients in each arm. In clinical practice approximately 9% patients for whom the dispatch office sends out an ambulance will end up being treated with IVT. Of these patients approximately 30% will be eligible for IAT and included for our primary endpoint. Therefore the investigators expect that for the inclusion of 150 IAT patients ending up being treated with IAT a wristband will have to be unpacked by ambulance personnel approximately 5000 times. Of these, approximately 500 patients will end up being treated with IVT; subsequently, from this population around 150 patients will be treated with IAT.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Zuid Holland
      • Leiden, Zuid Holland, Netherlands, 2333 ZA
        • Leiden University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients older than 18 years that are considered potentially eligible for IVT/IAT by the dispatch office, following regional EMS' standard stroke algorithm.

Exclusion Criteria:

  • age < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: real-time audio-visual feedback
real-time audio-visual feedback to caregivers (i.e. both in- and outside the hospital) bringing the patient to the location where IVT/IAT is administered . The real time audio-visual feedback consists in information on the actual TSD for a particular patient and whether or not this exceeds pre-set median time delay. The feedback is provided by handhelds in the ambulance and by pre-set monitors on different locations in the participating hospitals.
Other: real-time audio-visual feedback
real-time audio-visual feedback to caregivers on TSD (i.e. displaying time, a colour code which will provide an easy-view visualization on whether or not pre-set median time delays between locations are exceeded, and auditory signals indicating the elapsed time), displayed through handhelds and on pre-mounted tablets through the whole trajectory of acute stroke care
No Intervention: regular care
no real-time audio-visual feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
total system delay (TSD) to intraarterial thrombectomy (IAT)
Time Frame: 6 hours after symptom onset
6 hours after symptom onset
total system delay (TSD) to intravenous thrombolysis (IVT)
Time Frame: 4.5 hours after symptom onset
4.5 hours after symptom onset

Secondary Outcome Measures

Outcome Measure
Time Frame
number of patients eventually treated with intravenous thrombolysis (IVT) and/or intraarterial thrombectomy (IAT)
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years
symptomatic intracerebral haematoma (ICH)
Time Frame: 90 days after treatment (IVT/IAT)
90 days after treatment (IVT/IAT)
proportion of stroke mimics treated with intravenous thrombolysis (IVT) or intraarterial thrombectomy (IAT)
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years
functional outcome / modified Rankin Scale (mRS)
Time Frame: 90 days after treatment (IVT/IAT)
90 days after treatment (IVT/IAT)
differences between regions (urban/periferal)
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University

Collaborators

Leiden University Medical Center
The Dutch Brain Foundation
Innovation Fund Healthcare Insurers, the Netherlands

Investigators

  • Principal Investigator: Nyika D Kruyt, MD PhD, Leiden University Medical Center
  • Principal Investigator: Ale Algra, MD, professor, Leiden University Medical Center, the Netherlands. The Julius Centre, University Medical Centre Utrecht, The Netherlands.
  • Principal Investigator: Yvo BWEM Roos, MD, professor, Academical Medical Center, the Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 17, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Actual)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL 56747.058.016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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