Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies

Stroke Clinical Trial

— BIO-FAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04612218
• Other study ID #: BIO-FAST
• Status: Completed
• Start date: November 8, 2019
• Est. completion date: July 28, 2021

Study information

• Verified date: August 2021
• Source: Hospital Universitario Virgen Macarena
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: July 28, 2021
• Est. primary completion date: July 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
Spain	Hospital de Alta Resolución Sierra Norte	Sevilla
Spain	Hospital San Juan de Dios Aljarafe	Sevilla
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (5)

Lead Sponsor	Collaborator
Hospital Universitario Virgen Macarena	Hospital Alta Resolución Sierra Norte, Hospital San Juan de Dios Aljarafe, Hospital Universitario Reina Sofia de Cordoba, Hospitales Universitarios Virgen del Rocío

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke subtype diagnostic accuracy	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	through study completion, an average of 2 years
Primary	Reperfusion rates		through study completion, an average of 2 years
Primary	Times to reperfusion		through study completion, an average of 2 years