Potential Use of a POCT for the Direct Transfer of Stroke Patients From the Ambulance to the Thrombectomy Center

Study Overview
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Brief Summary
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Stroke is the leading cause of long-term disability and the second most common cause of death worldwide. Currently, the protocols require the imaging techniques at the hospitals to differ ischemic strokes with large vessel occlusion (LVO) from others. In this study, a duplex POC will be used in combination with an APP to identify LVO ischemic strokes in a 800 patients'cohort with pre-hospital and in-hospital blood samples.

Detailed Description
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Stroke is the leading cause of long-term disability and the second most common cause of death worldwide, accounting for around 6.7 million deaths each year. The burden of stroke due to illness, disability and early death is set to double within the next 15 years due to an ageing population. Currently, imaging techniques are required to differentiate ischemic strokes with large vessel occlusion (LVO) from others. Since those neuroimages cannot be easily done at a pre-hospital level, our objective is to develop a simple point-of-care test (POC) to differentiate between both ischemic strokes during the acute phase, which will allow in the future an earlier thrombectomy treatment and an improvement of the patient outcomes significantly. For that, the investigators will recruit a 800 patients' cohort with pre-hospital and in-hospital blood samples by a multiplex POC for the biomarker measurement using an APP in combination with clinical data to identify LVO ischemic strokes. Finally, an interim analysis is planned when 400 patients are recruited.

Official Title
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Study of the Potential Use of a Rapid Point-of-Care Device for the Direct Transfer of Stroke Patients From the Ambulance to the Thrombectomy Center

Conditions
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Stroke, Acute Ischemic

Intervention / Treatment
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* Device: Large Vessel Occlusion Biomarkers Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: I.1: Patients > 18 years old. I.2: Stroke code activated. I.3: < 6 hours from symptoms onset. In the case of stroke with uncertain chronology or wake-up stroke, the initial time will be considered as the last moment the patient was seen fine. Exclusion Criteria: E.1: Previous diagnosis different from stroke. E.2: Impossibility of getting a blood sample. E.3: Refusal to provide the informed consent by the patient/relative.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-hospital and in-hospital patients<br>Patients recruited at the ambulance (ARM A) and at the hospital (ARM B). | Device: Large Vessel Occlusion Biomarkers Test<br>* Duplex Point of Care test to measure the concentration of biomarkers associated to Large Vessel Occlusion in blood samples used in combination with an APP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the diagnosis accuracy of the algorithm LVOCheck (Specificity and sensibility) | Biomarkers Clinical data (gender, age, diabetes, dyslipidemia, atrial fibrillation, blood pressure) Neurologic scales (NIHSS, RACE, GFAST, Cincinatti) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viability of the implement of the tool at a pre-hospital environment | Estimated time in patients direct potentially transferred to the thrombectomy centers. Error rate in tool performance at a pre-hospital and hospital environment. Percentage of right use of the tool (human failares) at a pre-hospital and hospital environment. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Large Vessels Occlusion (LVO), Thrombectomy, Biomarkers, Point of care test (POCT)