Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies

Stroke is the first cause of death among Spanish women and main cause of disability. Reperfusion therapies of the occluded artery remain the only useful approach in acute ischemic stroke. However, the efficacy of these strategies is highly time-dependent and due to the need of neuroimaging (CT or MRI) to differentiate between ischemic and hemorrhagic stroke, impossible to be performed at the pre-hospital level. The investigators aim to set-up a point of-care (POC) device to validate a biomarker panel differentiating ischemic and hemorrhagic stroke at the pre-hospital level using a blood sample and to validate a second biomarker panel for the early identification of patients with large vessel occlusions (LVO), which are candidates for mechanical thrombectomy. For that, the investigators will recruit a 300 patients' cohort with pre-hospital blood samples using available POCs for each of those markers.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhagic Stroke Ischemic Stroke Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital San Juan de Dios Aljarafe, Seville, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

I.1: Patients > 18 years old.
I.2: Stroke code activated by the coordinator centre.
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: Prehospital diagnosis different of stroke.
E.2: Impossibility of getting a prehospital blood sample.
E.3: Refusal to provide the informed consent by the patient/relative.

Treatment and study plan

Primary outcomes

Stroke subtype diagnostic accuracy

Time frame: through study completion, an average of 2 years

Stroke subtype diagnostic (% ischemic versus % hemorrhagic and % stroke mimics) will be determined by clinical and neuroimaging criteria at hospital arrival and compared with diagnostic accuracy of a blood biomarkers based test
Reperfusion rates

Time frame: through study completion, an average of 2 years
Times to reperfusion

Time frame: through study completion, an average of 2 years

Sponsors and collaborators

Lead sponsor

Hospital Universitario Virgen Macarena

Other

Collaborators

Hospital Alta Resolución Sierra Norte
Hospital San Juan de Dios Aljarafe
Hospital Universitario Reina Sofia de Cordoba
Hospitales Universitarios Virgen del Rocío

Registry information

Official study title

Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies (BIO-FAST)

Acronym: BIO-FAST

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Nov 2, 2020
Registry last updated: Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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