Stroke, Acute Ischemic
Conditions
Keywords
Large Vessels Occlusion (LVO), Thrombectomy, Biomarkers, Point of care test (POCT)
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.
Interventions
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.
Sponsors
Hospital Universitario Virgen Macarena
Hospitales Universitarios Virgen del Rocío
Hospital Universitario Torrecárdenas
Hospital Universitario Poniente
Hospital Clínico Universitario Lozano Blesa
Hospital Miguel Servet
Hospital Universitario Royo Villanova
Hospital General San Jorge
Hospital San Pedro de Logroño
Hospital Clínico Universitario de Valladolid
Hospital Universitario La Fe
Complejo Hospitalario Universitario de Albacete
Hospital de Medina del Campo
Hospital General Río Carrión
Hospital General de Segovia
Hospital del Rio Hortega
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the diagnosis accuracy of the algorithm LVOCheck (Specificity and sensibility) | 6 months | * Biomarkers * Clinical data (gender, age, diabetes, dyslipidemia, atrial fibrillation, blood pressure) * Neurologic scales (NIHSS, RACE, GFAST, Cincinatti) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viability of the implement of the tool at a pre-hospital environment | 6 months | * 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. |
Countries
Spain
Outcome results
None listed