A Reduction in Time With Electronic Monitoring In Stroke (ARTEMIS)
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ClinicalTrials.gov Identifier: NCT02808806 |
Recruitment Status :
Terminated
(technical difficulties)
First Posted : June 22, 2016
Last Update Posted : September 30, 2020
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Condition or disease | Intervention/treatment | Phase |
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Acute Ischemic Stroke Stroke | Other: real-time audio-visual feedback | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 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 |
Actual Study Start Date : | December 1, 2017 |
Actual Primary Completion Date : | January 1, 2020 |
Actual Study Completion Date : | March 1, 2020 |

Arm | Intervention/treatment |
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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.
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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
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- total system delay (TSD) to intraarterial thrombectomy (IAT) [ Time Frame: 6 hours after symptom onset ]
- total system delay (TSD) to intravenous thrombolysis (IVT) [ Time Frame: 4.5 hours after symptom onset ]
- number of patients eventually treated with intravenous thrombolysis (IVT) and/or intraarterial thrombectomy (IAT) [ Time Frame: through study completion, an average of 2 years ]
- symptomatic intracerebral haematoma (ICH) [ Time Frame: 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 ]
- functional outcome / modified Rankin Scale (mRS) [ Time Frame: 90 days after treatment (IVT/IAT) ]
- differences between regions (urban/periferal) [ Time Frame: through study completion, an average of 2 years ]

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

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
Netherlands | |
Leiden University Medical Center | |
Leiden, Zuid Holland, Netherlands, 2333 ZA |
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | NyikaKruyt, N.D. Kruyt, PhD, Neurologist, Leiden University Medical Center |
ClinicalTrials.gov Identifier: | NCT02808806 |
Other Study ID Numbers: |
NL 56747.058.016 |
First Posted: | June 22, 2016 Key Record Dates |
Last Update Posted: | September 30, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
Stroke Ischemic Stroke Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |