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

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ClinicalTrials.gov Identifier: NCT02808806
Recruitment Status : Unknown
Verified July 2017 by NyikaKruyt, Leiden University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 22, 2016
Last Update Posted : July 24, 2017
Sponsor:
Collaborators:
The Dutch Brain Foundation
Innovation Fund Healthcare Insurers, the Netherlands
Information provided by (Responsible Party):
NyikaKruyt, Leiden University Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Stroke Other: real-time audio-visual feedback Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Reduction in Time With Electronic Monitoring In Stroke (ARTEMIS) Trial
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 2019
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. total system delay (TSD) to intraarterial thrombectomy (IAT) [ Time Frame: 6 hours after symptom onset ]
  2. total system delay (TSD) to intravenous thrombolysis (IVT) [ Time Frame: 4.5 hours after symptom onset ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808806


Contacts
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Contact: Nyika D Kruyt, MD PhD +31 (0)71 - 52 62197 n.d.kruyt@lumc.nl
Contact: Gaia T Koster, MD +31 (0)71 - 52 62118 g.t.koster@lumc.nl

Locations
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Netherlands
Leiden University Medical Center Not yet recruiting
Leiden, Zuid Holland, Netherlands, 2333 ZA
Contact: Nyika D Kruyt, MD PhD    +31 (0)71-52 62197    n.d.kruyt@lumc.nl   
Contact: Gaia T Koster, MD    +31 (0)71-52 62118    g.t.koster@lumc.nl   
Sponsors and Collaborators
Leiden University Medical Center
The Dutch Brain Foundation
Innovation Fund Healthcare Insurers, the Netherlands
Investigators
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Principal Investigator: Nyika D Kruyt, MD PhD Leiden University Medical Center
Principal Investigator: Marieke JH Wermer, 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
More Information
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Publications:
Berkhemer OA, Fransen PS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ, van Walderveen MA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama à Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van Dijk LC, Kappelle LJ, Lo RH, van Dijk EJ, de Vries J, de Kort PL, van Rooij WJ, van den Berg JS, van Hasselt BA, Aerden LA, Dallinga RJ, Visser MC, Bot JC, Vroomen PC, Eshghi O, Schreuder TH, Heijboer RJ, Keizer K, Tielbeek AV, den Hertog HM, Gerrits DG, van den Berg-Vos RM, Karas GB, Steyerberg EW, Flach HZ, Marquering HA, Sprengers ME, Jenniskens SF, Beenen LF, van den Berg R, Koudstaal PJ, van Zwam WH, Roos YB, van der Lugt A, van Oostenbrugge RJ, Majoie CB, Dippel DW; MR CLEAN Investigators. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015 Jan 1;372(1):11-20. doi: 10.1056/NEJMoa1411587. Epub 2014 Dec 17. Erratum in: N Engl J Med. 2015 Jan 22;372(4):394.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NyikaKruyt, N.D. Kruyt, PhD, Neurologist, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT02808806     History of Changes
Other Study ID Numbers: NL 56747.058.016
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NyikaKruyt, Leiden University Medical Center:
stroke
cerebral infarction
brain infarction
ischemic stroke
treatment
intravenous thrombolysis
intraarterial thrombectomy
 delay
total system delay
pre-hospital delay
in-hospital delay
feedback
real-time feedback
visual feedback
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases