CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 400 enrolled
Drug / intervention
FAST PLUS testother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03072524
NCT03072524N/ACompleted

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

University Hospital Ostrava·observational·Posted Mar 7, 2017·Updated Feb 19, 2019

In Brief

An observational study evaluating FAST PLUS test for Stroke. Completed, enrolled 400 participants across 4 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 7, 2017
Enrollment StartMar 1, 2016
Primary CompletionAug 31, 2018
Study CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.3 years ago

Interventions

FAST PLUS testother

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).