Acute Ischemic StrokeARTEMISNCT02808806
A Reduction in Time With Electronic Monitoring In Stroke
A study testing real-time audio-visual feedback in people with Acute Ischemic Stroke and Stroke, run by Leiden University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Stroke
- What is being tested?
- real-time audio-visual feedback
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2017to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients older than 18 years that are considered potentially eligible for IVT/IAT by the dispatch office, following regional EMS' standard stroke algorithm.
Who cannot join
- age < 18 years
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Ischemic Stroke, Stroke
- Being tested
- real-time audio-visual feedback
- Keywords
- 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
- Medical subject headings
- Ischemic Stroke, Stroke, Cerebral Infarction, Brain Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: real-time audio-visual feedback |
| regular care | No intervention | no real-time audio-visual feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
total system delay (TSD) to intraarterial thrombectomy (IAT)
Measured: 6 hours after symptom onset
total system delay (TSD) to intravenous thrombolysis (IVT)
Measured: 4.5 hours after symptom onset
Secondary outcomes (5)
number of patients eventually treated with intravenous thrombolysis (IVT) and/or intraarterial thrombectomy (IAT)
Measured: through study completion, an average of 2 years
symptomatic intracerebral haematoma (ICH)
Measured: 90 days after treatment (IVT/IAT)
proportion of stroke mimics treated with intravenous thrombolysis (IVT) or intraarterial thrombectomy (IAT)
Measured: through study completion, an average of 2 years
functional outcome / modified Rankin Scale (mRS)
Measured: 90 days after treatment (IVT/IAT)
differences between regions (urban/periferal)
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study start1 Dec 2017
- Primary completion1 Jan 2020
- Study completion1 Mar 2020
Why it stopped: technical difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University
- Sponsor type
- University, hospital or other
- Collaborators
- The Dutch Brain Foundation, Innovation Fund Healthcare Insurers, the Netherlands, Leiden University Medical Center
- Responsible party
- Principal investigator, NyikaKruyt, Leiden University Medical Center
- Investigators
- Nyika D Kruyt, MD PhD, Principal investigator, Leiden University Medical CenterMarieke JH Wermer, MD PhD, Principal investigator, Leiden University Medical CenterAle Algra, MD, professor, Principal investigator, Leiden University Medical Center, the Netherlands. The Julius Centre, University Medical Centre Utrecht, The Netherlands.Yvo BWEM Roos, MD, professor, Principal investigator, Academical Medical Center, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808806
- Sponsor's protocol ID
- NL 56747.058.016
- Acronym
- ARTEMIS
- Status last verified
- Sep 2020
- First submitted
- 14 Jun 2016
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 18815396Berkhemer 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.
PubMed 25517348Jovin 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.
PubMed 25882510Goyal 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.
PubMed 25671798Campbell 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.
PubMed 25671797Saver 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.
PubMed 25882376Furlan 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.
PubMed 25882509Saver 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.
PubMed 23780461Kruyt 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.
PubMed 24052509Ghrooda 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.
PubMed 23041399Ruff 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.
PubMed 24399372Burnett 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.
PubMed 25352486Todt 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.
PubMed 24002986He 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.
PubMed 25918863Koster 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.
PubMed 29950465
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Reduction in Time With Electronic Monitoring In Stroke (ARTEMIS) Trial
- ClinicalTrials.gov ID
- NCT02808806
- Acronym / sponsor ID
- ARTEMIS / NL 56747.058.016
- Conditions
- Acute Ischemic Stroke, Stroke
- Keywords
- stroke, cerebral infarction, brain infarction, ischemic stroke, treatment, intravenous thrombolysis, intraarterial thrombectomy, delay
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: technical difficulties
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Leiden UniversityUniversity, hospital or other
- Collaborators
- The Dutch Brain Foundation, Innovation Fund Healthcare Insurers, the Netherlands, Leiden University Medical Center
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real-time audio-visual feedback | Active comparator | Other: real-time audio-visual feedbackreal-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. |
| regular care | No intervention | –no real-time audio-visual feedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients older than 18 years that are considered potentially eligible for IVT/IAT by the dispatch office, following regional EMS' standard stroke algorithm.
Key exclusion criteria (1 listed)
- age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real-time audio-visual feedbackreal-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 | Other | real-time audio-visual feedback |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: technical difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Background: PubMed 18815396Hacke 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.
- Background: PubMed 25517348Berkhemer 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.
- Background: PubMed 25882510Jovin 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.
- Background: PubMed 25671798Goyal 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.
- Background: PubMed 25671797Campbell 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.
- Background: PubMed 25882376Saver 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.
- Background: PubMed 25882509Furlan 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.
- Background: PubMed 23780461Saver 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.
- Background: PubMed 24052509Kruyt 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.
- Background: PubMed 23041399Ghrooda 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.
- Background: PubMed 24399372Ruff 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.
- Background: PubMed 25352486Burnett 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nyika D Kruyt, MD PhD principal investigator
Leiden University Medical Center
Marieke JH Wermer, MD PhD principal investigator
Leiden University Medical Center
Ale Algra, MD, professor principal investigator
Leiden University Medical Center, the Netherlands. The Julius Centre, University Medical Centre Utrecht, The Netherlands.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real-time audio-visual feedback in people with Acute Ischemic Stroke and Stroke, run by Leiden University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: technical difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total system delay (TSD) to intraarterial thrombectomy (IAT) (time frame: 6 hours after symptom onset). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02808806, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2020.