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The Prehospital Selection of Acute Stroke Patients

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ClinicalTrials.gov Identifier: NCT03072524
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : March 23, 2018
Sponsor:
Collaborators:
Ostrava University, Faculty of Medicine
Agel Research and Training Institute, Vítkovice Hospital, Ostrava, Czech Republic
Emergency Medical Service Ostrava, Ostrava, Czech Republic
Municipal Hospital Ostrava, Ostrava, Czech Republic
St. Anne's University Hospital, Medical Faculty, Masaryk University, Brno, Czech Republic
Angels Initiative, European Stroke Organisation, Czech branch
Information provided by (Responsible Party):
University Hospital Ostrava

Brief 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. 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.

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.


Condition or disease Intervention/treatment
Stroke Diagnostic Test: FAST PLUS test

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of Prehospital Stroke Scale (FAST PLUS TEST) to Predict Patients With Large Arterial Vessel Intracranial Occlusion.
Actual Study Start Date : March 1, 2016
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : October 1, 2018

Group/Cohort Intervention/treatment
Stroke patients
Stroke patients who will undergo the FAST PLUS test within 12 hours from the stroke onset.
Diagnostic Test: FAST PLUS 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).




Primary Outcome Measures :
  1. Sensitivity, specificity, positive, negative predictive value and accuracy [ Time Frame: 21 months ]
    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.


Secondary Outcome Measures :
  1. Inter-rater variability [ Time Frame: 21 months ]
    Inter-rater variability between emergency technicians and stroke specialist in stroke severity (hemiparesis) assessment.


Other Outcome Measures:
  1. Time to hospital [ Time Frame: 21 months ]
    The time from the arriving of emergency service on site of stroke to door of hospital (comprehensive stroke center) after implementation of FAST PLUS test to the daily medical practice. We compare the time before and after the implementation of FAST PLUS test to daily clinical practice.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pre-hospital suspected stroke patients according to FAST PLUS test.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT03072524


Contacts
Contact: Vaclav Prochazka, MD,PhD,MSc +42059737 ext 2544 vaclav.prochazka@fno.cz
Contact: Jiri Hyncica +42059737 ext 2587 jiri.hyncica@fno.cz

Locations
Czechia
Emergency Medical Service Ostrava Recruiting
Ostrava, Moravian-Silesian Region, Czechia, 70030
Contact: David Holeš, MD    +42095073 ext 0401    zzsmsk@zzsmsk.cz   
Principal Investigator: David Holeš, MD         
Ostrava University Recruiting
Ostrava, Moravian-Silesian Region, Czechia, 70103
Contact: Daniel Václavík, MD    +42059563 ext 3440    daniel.vaclavik@osu.cz   
Principal Investigator: Daniel Václavík, MD         
Agel Research and Training Institute, Ostrava Vitkovice Hospital, Czech Republic Recruiting
Ostrava, Moravian-Silesian Region, Czechia, 70300
Contact: Daniel Václavík, MD    +42059563 ext 3440    daniel.vaclavik@osu.cz   
Principal Investigator: Daniel Václavík, MD         
Municipal Hospital Ostrava Recruiting
Ostrava, Moravian-Silesian Region, Czechia, 728 80
Contact: Lukáš Klečka, MD    +42055654 ext 1111    mnof@mnof.cz   
Principal Investigator: Lukáš Klečka, MD         
Sponsors and Collaborators
University Hospital Ostrava
Ostrava University, Faculty of Medicine
Agel Research and Training Institute, Vítkovice Hospital, Ostrava, Czech Republic
Emergency Medical Service Ostrava, Ostrava, Czech Republic
Municipal Hospital Ostrava, Ostrava, Czech Republic
St. Anne's University Hospital, Medical Faculty, Masaryk University, Brno, Czech Republic
Angels Initiative, European Stroke Organisation, Czech branch
Investigators
Principal Investigator: Michal Bar, Ass.Prof.,MD,PhD University Hospital Ostrava

Additional Information:
Publications:

Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT03072524     History of Changes
Other Study ID Numbers: FNO-NK-1
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Ostrava:
pre-hospital stroke scale test
severe hemiparesis
large vessel occlusion
mechanical thrombectomy

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases