Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06024330 |
| Other study ID # |
KU GOEK-2022/06.15 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
November 1, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Kocaeli University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
In acute ischemic stroke, treatments include intravenous thrombolysis (IVT) and mechanical
thrombectomy (MT). IVT is viable up to 4.5 hours post-stroke onset, while MT is applicable
within 24 hours but primarily for large vessel occlusions. MT is specialized and performed in
select stroke centers. Effective early triage improves neurological outcomes. Pre-hospital
stroke severity assessment and direct transfers for MT are crucial. Although the National
Institute of Health Stroke Scale (NIHSS) is widely recognized, its practicality is limited in
emergency settings due to its complexity. Alternative scoring systems like LAMS, CPSS, and
RACE have been introduced but have limitations. Recently developed scores, namely Vision,
Aphasia, and Neglect (VAN), Ventura Emergency Large Vessel Occlusion (VES), and Large Artery
Intracranial Occlusion Stroke Scale (LARIO), demonstrate promising diagnostic accuracy in
pilot studies, suggesting potential benefits for early detection, appropriate triage, and
better neurological outcomes
Description:
For acute ischemic stroke, time-dependent treatments include intravenous thrombolysis (IVT)
and mechanical thrombectomy (MT). IVT can be considered in all patients with acute ischemic
stroke within the first 4.5 hours after the last known well time. However, MT can only be
applied within the first 24 hours in large vessel occlusions defined as acute occlusion of
the intracranial internal carotid artery (ICA), proximal posterior, middle, and anterior
cerebral arteries (respectively PCA, MCA, ACA), intracranial vertebral artery and/or basilar
artery. However, MT can only be performed in stroke centers specialized in this area.
Effective triage of large vessel occlusion and early application of emergency stroke
protocols are associated with good neurological outcomes. In this sense, pre-hospital
determination of stroke severity and direct transfer of patients requiring MT to the stroke
center are recommended by current guidelines. It is important that the protocols used in
pre-hospital and emergency department triage to determine stroke severity are easy to learn
and apply, are repeatable, and their accuracy is proven with external data sets. To date,
many scoring systems have been proposed for early determination of stroke severity. Although
the most accepted and widely used system among these systems is the National Institute of
Health Stroke Scale (NIHSS), the need for training and experience for practitioners and the
time-consuming application restrict its use in pre-hospital or emergency department triage.
Alternatively, short and easily applicable systems such as The Los Angeles Motor Scale
(LAMS), The Cincinnati Prehospital Stroke Scale (CPSS), Rapid Arterial oCclusion Evaluation
(RACE) have been developed in the pre-hospital setting. However, the inability of these
systems to provide high sensitivity and specificity together has necessitated the development
of other alternative scoring systems. Among the new scoring systems developed in recent
years, the Vision, Aphasia, and Neglect (VAN) score, the Ventura Emergency Large Vessel
Occlusion (VES) score, and the Large Artery Intracranial Occlusion Stroke Scale (LARIO) have
shown high diagnostic performance in pilot studies. The VAN score was shown to be 100%
sensitive and 90% specific in predicting large vessel occlusion in stroke patients with motor
weakness accompanied by at least one of the symptoms of vision, aphasia, and neglect or an
NIHSS score of >6. The VES score was developed as a 4-step system evaluating eye deviation,
aphasia, neglect, and lethargy, and it was reported that the presence of at least one of
these functions was 95% sensitive and 82% specific in predicting large vessel occlusion. The
LARIO score was developed as a 5-step system evaluating facial paralysis, speech disorder,
arm weakness, hand grip weakness, and neglect. Having >3 of these steps positive provided
100% sensitivity and 82% specificity for large vessel occlusion. The results obtained from
pilot studies suggest that the use of VAN, VES, and LARIO scoring systems in pre-hospital or
emergency department triage promises to improve neurological outcomes by early identification
of patients with large vessel occlusion requiring MT, appropriate triage, and optimal
application of stroke protocols
