NCT02808806

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
1.4 years until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

2.1 years

First QC Date

June 14, 2016

Last Update Submit

September 28, 2020

Conditions

Acute Ischemic StrokeStroke

Keywords

strokecerebral infarctionbrain infarctionischemic stroketreatmentintravenous thrombolysisintraarterial thrombectomydelaytotal system delaypre-hospital delayin-hospital delayfeedbackreal-time feedbackvisual feedback

Outcome Measures

Primary Outcomes (2)

  • total system delay (TSD) to intraarterial thrombectomy (IAT)

    6 hours after symptom onset

  • total system delay (TSD) to intravenous thrombolysis (IVT)

    4.5 hours after symptom onset

Secondary Outcomes (5)

  • number of patients eventually treated with intravenous thrombolysis (IVT) and/or intraarterial thrombectomy (IAT)

    through study completion, an average of 2 years

  • symptomatic intracerebral haematoma (ICH)

    90 days after treatment (IVT/IAT)

  • proportion of stroke mimics treated with intravenous thrombolysis (IVT) or intraarterial thrombectomy (IAT)

    through study completion, an average of 2 years

  • functional outcome / modified Rankin Scale (mRS)

    90 days after treatment (IVT/IAT)

  • differences between regions (urban/periferal)

    through study completion, an average of 2 years

Study Arms (2)

real-time audio-visual feedback

ACTIVE COMPARATOR

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

regular care

NO INTERVENTION

no real-time audio-visual feedback

Interventions

real-time audio-visual feedbackOTHER

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

real-time audio-visual feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

Related Publications (15)

  • Hacke W, Kaste M, Bluhmki E, Brozman M, Davalos A, Guidetti D, Larrue V, Lees KR, Medeghri Z, Machnig T, Schneider D, von Kummer R, Wahlgren N, Toni D; ECASS Investigators. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med. 2008 Sep 25;359(13):1317-29. doi: 10.1056/NEJMoa0804656.

    PMID: 18815396BACKGROUND

  • 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 a 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.

    PMID: 25517348BACKGROUND

  • Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Roman L, Serena J, Abilleira S, Ribo M, Millan M, Urra X, Cardona P, Lopez-Cancio E, Tomasello A, Castano C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Perez M, Goyal M, Demchuk AM, von Kummer R, Gallofre M, Davalos A; REVASCAT Trial Investigators. Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015 Jun 11;372(24):2296-306. doi: 10.1056/NEJMoa1503780. Epub 2015 Apr 17.

    PMID: 25882510BACKGROUND

  • Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL, Dowlatshahi D, Frei DF, Kamal NR, Montanera WJ, Poppe AY, Ryckborst KJ, Silver FL, Shuaib A, Tampieri D, Williams D, Bang OY, Baxter BW, Burns PA, Choe H, Heo JH, Holmstedt CA, Jankowitz B, Kelly M, Linares G, Mandzia JL, Shankar J, Sohn SI, Swartz RH, Barber PA, Coutts SB, Smith EE, Morrish WF, Weill A, Subramaniam S, Mitha AP, Wong JH, Lowerison MW, Sajobi TT, Hill MD; ESCAPE Trial Investigators. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015 Mar 12;372(11):1019-30. doi: 10.1056/NEJMoa1414905. Epub 2015 Feb 11.

    PMID: 25671798BACKGROUND

  • Campbell BC, Mitchell PJ, Kleinig TJ, Dewey HM, Churilov L, Yassi N, Yan B, Dowling RJ, Parsons MW, Oxley TJ, Wu TY, Brooks M, Simpson MA, Miteff F, Levi CR, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Priglinger M, Ang T, Scroop R, Barber PA, McGuinness B, Wijeratne T, Phan TG, Chong W, Chandra RV, Bladin CF, Badve M, Rice H, de Villiers L, Ma H, Desmond PM, Donnan GA, Davis SM; EXTEND-IA Investigators. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med. 2015 Mar 12;372(11):1009-18. doi: 10.1056/NEJMoa1414792. Epub 2015 Feb 11.

    PMID: 25671797BACKGROUND

  • Saver JL, Goyal M, Bonafe A, Diener HC, Levy EI, Pereira VM, Albers GW, Cognard C, Cohen DJ, Hacke W, Jansen O, Jovin TG, Mattle HP, Nogueira RG, Siddiqui AH, Yavagal DR, Baxter BW, Devlin TG, Lopes DK, Reddy VK, du Mesnil de Rochemont R, Singer OC, Jahan R; SWIFT PRIME Investigators. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015 Jun 11;372(24):2285-95. doi: 10.1056/NEJMoa1415061. Epub 2015 Apr 17.

    PMID: 25882376BACKGROUND

  • Furlan AJ. Endovascular therapy for stroke--it's about time. N Engl J Med. 2015 Jun 11;372(24):2347-9. doi: 10.1056/NEJMe1503217. Epub 2015 Apr 17. No abstract available.

    PMID: 25882509BACKGROUND

  • Saver JL, Fonarow GC, Smith EE, Reeves MJ, Grau-Sepulveda MV, Pan W, Olson DM, Hernandez AF, Peterson ED, Schwamm LH. Time to treatment with intravenous tissue plasminogen activator and outcome from acute ischemic stroke. JAMA. 2013 Jun 19;309(23):2480-8. doi: 10.1001/jama.2013.6959.

    PMID: 23780461BACKGROUND

  • Kruyt ND, Nederkoorn PJ, Dennis M, Leys D, Ringleb PA, Rudd AG, Vermeulen M, Stam J, Hacke W, Roos YB. Door-to-needle time and the proportion of patients receiving intravenous thrombolysis in acute ischemic stroke: uniform interpretation and reporting. Stroke. 2013 Nov;44(11):3249-53. doi: 10.1161/STROKEAHA.113.001885. Epub 2013 Sep 19. No abstract available.

    PMID: 24052509BACKGROUND

  • Ghrooda E, Alcock S, Jackson AC. Improvement in thrombolytic therapy administration in acute stroke with feedback. Can J Neurol Sci. 2012 Nov;39(6):789-92. doi: 10.1017/s0317167100015626.

    PMID: 23041399BACKGROUND

  • Ruff IM, Ali SF, Goldstein JN, Lev M, Copen WA, McIntyre J, Rost NS, Schwamm LH. Improving door-to-needle times: a single center validation of the target stroke hypothesis. Stroke. 2014 Feb;45(2):504-8. doi: 10.1161/STROKEAHA.113.004073. Epub 2014 Jan 7.

    PMID: 24399372BACKGROUND

  • Burnett MM, Zimmermann L, Coralic Z, Quon T, Whetstone W, Kim AS. Simple text-messaging intervention is associated with improved door-to-needle times for acute ischemic stroke. Stroke. 2014 Dec;45(12):3714-6. doi: 10.1161/STROKEAHA.114.007294. Epub 2014 Oct 28.

    PMID: 25352486BACKGROUND

  • Todt T, Thylen I, Alfredsson J, Swahn E, Janzon M. Strategies TO reduce time delays in patients with AcuTe coronary heart disease treated with primary PCI--the STOP WATCH study: a multistage action research project. BMJ Open. 2013 Sep 3;3(9):e003493. doi: 10.1136/bmjopen-2013-003493.

    PMID: 24002986BACKGROUND

  • He AH, Churilov L, Mitchell PJ, Dowling RJ, Yan B. Every 15-min delay in recanalization by intra-arterial therapy in acute ischemic stroke increases risk of poor outcome. Int J Stroke. 2015 Oct;10(7):1062-7. doi: 10.1111/ijs.12495. Epub 2015 Apr 28.

    PMID: 25918863BACKGROUND

  • Koster GT, Nguyen TTM, Groot AED, Coutinho JM, Bosch J, den Hertog HM, van Walderveen MAA, Algra A, Wermer MJH, Roos YB, Kruyt ND; ARTEMIS investigators. A Reduction in Time with Electronic Monitoring In Stroke (ARTEMIS): study protocol for a randomised multicentre trial. BMJ Open. 2018 Jun 27;8(6):e020844. doi: 10.1136/bmjopen-2017-020844.

    PMID: 29950465DERIVED

MeSH Terms

Conditions

Ischemic StrokeStrokeCerebral InfarctionBrain Infarction

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain IschemiaInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
N.D. Kruyt, PhD, Neurologist

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 22, 2016

Study Start

December 1, 2017

Primary Completion

January 1, 2020

Study Completion

March 1, 2020

Last Updated

September 30, 2020

Record last verified: 2020-09

Locations

NL(1)