Stroke Clinical Trial
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.
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.
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:
A) 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.
B) 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) .
C) 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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Suspended |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Enrolling by invitation |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Active, not recruiting |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Recruiting |
NCT05993221 -
Deconstructing Post Stroke Hemiparesis
|