AzTrials
AzTrials

StrokeNCT03072524

The Prehospital Selection of Acute Stroke Patients

An observational study of Stroke, run by University Hospital Ostrava at 4 sites in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of this study is to develop and validate a simple prehospital stroke scale, which would predict the presence of large vessel occlusion (LVO) in patients with acute stroke. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
FAST PLUS test
How many people
400 participants
Where
4 sitesCzechia
Study dates
1 Mar 2016to 1 Oct 2018
Phase
Observational
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

Study population: Pre-hospital suspected stroke patients according to FAST PLUS test.

Who may be able to join

  • Acute ischemic stroke
  • FAST PLUS test evaluation performed by emergency technicians
  • CT,CT angiography evaluation performed up to 12 hours from stroke onset

Who cannot join

  • Non ischemic stroke etiology of acute neurological deficit
  • More than 12 hours from the symptoms onset

Trial locations and contacts

4 sites in 1 country.

Czechia4 sites
  • Emergency Medical Service Ostrava

    Ostrava, Moravian-Silesian Region, 70030

  • Ostrava University

    Ostrava, Moravian-Silesian Region, 70103

  • Agel Research and Training Institute, Ostrava Vitkovice Hospital, Czech Republic

    Ostrava, Moravian-Silesian Region, 70300

  • Municipal Hospital Ostrava

    Ostrava, Moravian-Silesian Region, 728 80

Other trials in Czechia

About this study

Official title: Validation of Prehospital Stroke Scale (FAST PLUS TEST) to Predict Patients With Large Arterial Vessel Intracranial Occlusion.

The aim of this study is to develop and validate a simple prehospital stroke scale, which would predict the presence of large vessel occlusion (LVO) in patients with acute stroke. This study prospectively evaluates the predictive value of a new simple pre-hospital scale (FAST PLUS test) for the presence of large vessel occlusion in anterior intracranial circulation. The FAST PLUS test consists of two parts: the first is the well-known FAST test, which is employed in all possible cases of stroke occurrence. This test consists of the following items: Speech (scored 0-1), Facial palsy (0-1), any failure of Arm motor function (0-1), and Time (0-1). The second part of FAST PLUS test evaluates only the presence of severe arm or leg motor deficit (scored 0-1) and unilateral occurrence of its motor function deficit (scored 0-1).

The FAST PLUS test will be used prospectively at the place of stroke onset by trained medical emergency technicians. The first objective of study is to evaluate the sensitivity, specificity, and the positive and negative predictive value of the test which relate to the presence of occlusion of intracranial artery (intracranial carotid artery, T occlusion and occlusion of Middle Cerebral artery segment M1 and M2). CT angiography can only diagnose the LVO.

Read more

The second objective of this study is to assess inter-rater variability among stroke specialists and emergency technicians, concerning the presence of severe motor arm or leg deficit.

The third objective : After implementation of the FAST TEST to clinical practice, we aim to achieve the acceleration of transport time in FAST PLUS positive patients via direct transport to Comprehensive Stroke Center to mechanical thrombectomy.

Read the detailed description

The effective treatment of acute ischemic stroke is limited to administration of intravenous tissue-type plasminogen activator within the first 4.5 hours from symptoms onset or endovascular thrombectomy up to 6(8) hours from the symptoms onset. Intravenous thrombolysis can be administered in the nearest Primary Stroke Centers (PSC).

In the case of large vessel occlusion, the endovascular therapy (mechanical thrombectomy) is utilized. Mechanical thrombectomy is offered only in Comprehensive Stroke Centers (CSC), due to the necessary presence of the special endovascular team during the procedure.

Practically, there are two options to transport patients for endovascular treatment. If the first one is used, then all suspected stroke patients are transported to primary stroke centers only. Then, rapid examinations are provided and, if the patient is determined to be having a stroke, the administration of intravenous thrombolysis occurs. Patients with diagnosis of stroke and large vessel occlusion are consequently transported to Comprehensive Stroke Center in order to receive mechanical thrombectomy. This first choice accelerates thrombolysis administration but delays endovascular procedures.

The second option entails selection of patients with suspected LVO stroke on site of stroke onset, and such patients are directly transported to Comprehensive Stroke Centers. The second choice accelerates endovascular procedures, but may delay intravenous thrombolysis. The disadvantage of this might be the overloading of the CSC with misdiagnosed patients (stroke mimics or non LVO stroke patients).

We can identify suspected stroke patients pre-hospitably with relative accuracy. The FAST test is a very simple and highly specific tool to identify stroke patients.* It consists of four items Face, Arm, Speech, and Time. Unfortunately, the FAST test is not able to evaluate the severity of the stroke, which is probably linked to the occlusion of large artery.

The only one test (RACE test) was prospectively studied to evaluate its sensitivity and specificity for diagnosis of large vessel occlusion.

In the hospital (stroke centre), we recognize the stroke severity according to NIHS scale, but both these scales are not suitable for emergency service for its difficulty.

Therefore, we desined a very simple new test - FAST PLUS test for the identification of the severe stroke patients on site, immediately at the onset of stroke. FAST PLUS test consists of two parts: the first one is the well-known FAST test which selects all suspected stroke patients and consists of the following evaluations: Speech (scored 0-1), Facial palsy (0-1), any failure of Arm motor function (0-1), time (0-1). The time means the speed of onset of symptoms during 30 minutes. The second part of the FAST PLUS test evaluates only the presence of severe arm or leg motor deficit (scored 0-1) and the unilateral occurrence of this motor function deficit (scored 0-1). (Figure one) The working hypothesis: We assume that the patients with clinically severe stroke and positive FAST PLUS test have a high probability of the presence of large cerebral vessel occlusion.

The aims of study:

  1. The validation of the new pre-hospital test - FAST PLUS - to identify the stroke patients with LVO. The objective of our study is to evaluate the predictive value of the FAST PLUS test in the detection of patients with acute stroke and large vessel occlusion (LVO) when it is used by medical emergency technicians during the pre-hospital phase.

We presume that stroke severity, according to item 4 and 5 in NIHSS is linked to occlusion of ACM M1 or intracranial ICA. The FAST PLUS test consists of two parts (fig. 1), the first one is FAST test for identifying patients with stroke. The second part of test has three items, and evaluates the severity of hemiparesis and unilateral disabilities. The FAST PLUS test is positive when at least two items are positive in the first part (Time must be always positive + the presence of one of three symptoms at least) and all three items are positive in the second part.

  1. The second aim of study is to determine the inter-rater variability between emergency technician and stroke specialist in evaluation NIHS scale, items 4 and 5 only. The agreement means the agreement in the severe hemiparesis evaluation between paramedics (FAST PLUS test positive) and stroke specialist examination(NIHSS 3 or 4 points in item 4,5 NIHSS) .
  2. The third aim of study is to shorten the time between the onset of stroke to hospital entry or the time from the arriving of emergency service on site of stroke to hospital door after implementation of FAST PLUS test to the daily medical practice.

The first phase:

The creation of educational material for emergency technicians. The second phase: The education and testing of emergency technicians via e-learning and web seminars. The aim of the education is to learn whether the Emergency service is using the FAST PLUS test correctly.

We plan 6 months time period for the first and the second phase of study.

The third phase:

A/ to collect 400 FAST PLUS tests from the stroke patients up to 12 hours from the stroke onset to hospital arrival.

B/ to calculate the primary secondary and tertiary outcome measures of study

We plan 12 months time period for the third phase of study.

For statistical analysis, X software was used. Receiver operating curves and areas under receiver operating curve (c-statistics) were calculated as a measure of predictive ability for LVO of the FAST plus test. Ideal prediction produces a c-statistic of 1.00; precision no better than chance is associated with c-statistic of ≤0.50. Correlation between both scales (FAST test second part and NIHSS items 4 and 5) was analyzed with the nonparametric Spearman coefficient.

Cross tables for different cutoff values of the FAST plus test were used to evaluate sensitivity, specificity, positive predictive value, negative predictive values, and overall accuracy for the presence of VO.

Conditions
Stroke
Being tested
FAST PLUS test
Keywords
pre-hospital stroke scale test, severe hemiparesis, large vessel occlusion, mechanical thrombectomy
Medical subject headings
Stroke, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FAST PLUS testDiagnostic test

    FAST PLUS test consists of two parts: the first one is the standard FAST test, which evaluates Speech (0-1), Facial palsy (0-1), Arm motor function (0-1), Time (0-1). The second part of the FAST PLUS test evaluates only the presence of severe arm or leg motor deficit (0-1), and unilateral occurrence of this motor function deficit (0-1).

Study groups in NCT03072524
Study groupRoleWhat they receive
Stroke patientsStroke patients who will undergo the FAST PLUS test within 12 hours from the stroke onset.
Receives: Diagnostic Test: FAST PLUS test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity, specificity, positive, negative predictive value and accuracy

    Sensitivity, specificity, positive, negative predictive value of the test and overall accuracy with the presence of large vessel occlusion will be assessed. The presence of LVO will be diagnosed by CT Angiography only as soon as the patient enters the hospital.

    Measured: 21 months

Secondary outcomes (1)
  1. Inter-rater variability

    Inter-rater variability between emergency technicians and stroke specialist in stroke severity (hemiparesis) assessment.

    Measured: 21 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2017
  2. Study start1 Mar 2016
  3. Primary completion31 Aug 2018
  4. Study completion1 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03072524
Sponsor's protocol ID
FNO-NK-1
Status last verified
Feb 2019
First submitted
1 Mar 2017
Last updated
19 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Perez de la Ossa N, Carrera D, Gorchs M, Querol M, Millan M, Gomis M, Dorado L, Lopez-Cancio E, Hernandez-Perez M, Chicharro V, Escalada X, Jimenez X, Davalos A. Design and validation of a prehospital stroke scale to predict large arterial occlusion: the rapid arterial occlusion evaluation scale. Stroke. 2014 Jan;45(1):87-91. doi: 10.1161/STROKEAHA.113.003071. Epub 2013 Nov 26.

    PubMed 24281224
  • Nazliel B, Starkman S, Liebeskind DS, Ovbiagele B, Kim D, Sanossian N, Ali L, Buck B, Villablanca P, Vinuela F, Duckwiler G, Jahan R, Saver JL. A brief prehospital stroke severity scale identifies ischemic stroke patients harboring persisting large arterial occlusions. Stroke. 2008 Aug;39(8):2264-7. doi: 10.1161/STROKEAHA.107.508127. Epub 2008 Jun 12.

    PubMed 18556587
  • Singer OC, Dvorak F, du Mesnil de Rochemont R, Lanfermann H, Sitzer M, Neumann-Haefelin T. A simple 3-item stroke scale: comparison with the National Institutes of Health Stroke Scale and prediction of middle cerebral artery occlusion. Stroke. 2005 Apr;36(4):773-6. doi: 10.1161/01.STR.0000157591.61322.df. Epub 2005 Feb 24.

    PubMed 15731478
  • Puolakka T, Kuisma M, Lankimaki S, Puolakka J, Hallikainen J, Rantanen K, Lindsberg PJ. Cutting the Prehospital On-Scene Time of Stroke Thrombolysis in Helsinki: A Prospective Interventional Study. Stroke. 2016 Dec;47(12):3038-3040. doi: 10.1161/STROKEAHA.116.014531. Epub 2016 Nov 8.

    PubMed 27827326
  • Lima FO, Silva GS, Furie KL, Frankel MR, Lev MH, Camargo EC, Haussen DC, Singhal AB, Koroshetz WJ, Smith WS, Nogueira RG. Field Assessment Stroke Triage for Emergency Destination: A Simple and Accurate Prehospital Scale to Detect Large Vessel Occlusion Strokes. Stroke. 2016 Aug;47(8):1997-2002. doi: 10.1161/STROKEAHA.116.013301. Epub 2016 Jun 30.

    PubMed 27364531
  • Heldner MR, Zubler C, Mattle HP, Schroth G, Weck A, Mono ML, Gralla J, Jung S, El-Koussy M, Ludi R, Yan X, Arnold M, Ozdoba C, Mordasini P, Fischer U. National Institutes of Health stroke scale score and vessel occlusion in 2152 patients with acute ischemic stroke. Stroke. 2013 Apr;44(4):1153-7. doi: 10.1161/STROKEAHA.111.000604. Epub 2013 Mar 7.

    PubMed 23471266
  • Hastrup S, Damgaard D, Johnsen SP, Andersen G. Prehospital Acute Stroke Severity Scale to Predict Large Artery Occlusion: Design and Comparison With Other Scales. Stroke. 2016 Jul;47(7):1772-6. doi: 10.1161/STROKEAHA.115.012482. Epub 2016 Jun 7.

    PubMed 27272487
  • Meyer BC, Lyden PD. The modified National Institutes of Health Stroke Scale: its time has come. Int J Stroke. 2009 Aug;4(4):267-73. doi: 10.1111/j.1747-4949.2009.00294.x.

    PubMed 19689755
  • Harbison J, Hossain O, Jenkinson D, Davis J, Louw SJ, Ford GA. Diagnostic accuracy of stroke referrals from primary care, emergency room physicians, and ambulance staff using the face arm speech test. Stroke. 2003 Jan;34(1):71-6. doi: 10.1161/01.str.0000044170.46643.5e.

    PubMed 12511753
  • Vaclavik D, Bar M, Klecka L, Holes D, Cabal M, Mikulik R. Prehospital stroke scale (FAST PLUS Test) predicts patients with intracranial large vessel occlusion. Brain Behav. 2018 Sep;8(9):e01087. doi: 10.1002/brb3.1087. Epub 2018 Aug 7.

    PubMed 30085409

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by University Hospital Ostrava at 4 sites in Czechia.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Czechia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Sensitivity, specificity, positive, negative predictive value and accuracy (time frame: 21 months). 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 NCT03072524, which also lists 10 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 19 Feb 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in