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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke, Acute Ischemic
- Sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Enrollment
- 355
- Locations
- 16
- Primary Endpoint
- Evaluation of the diagnosis accuracy of the algorithm LVOCheck (Specificity and sensibility)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Evaluation of the diagnosis accuracy of the algorithm LVOCheck (Specificity and sensibility)
Time Frame: 6 months
* Biomarkers * Clinical data (gender, age, diabetes, dyslipidemia, atrial fibrillation, blood pressure) * Neurologic scales (NIHSS, RACE, GFAST, Cincinatti)
Secondary Outcomes
- Viability of the implement of the tool at a pre-hospital environment(6 months)