Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2026-01-12 @ 12:39 PM
Study NCT ID:
NCT04612218
Status:
COMPLETED
Last Update Posted:
2021-08-26
First Post:
2020-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies
Sponsor:
Hospital Universitario Virgen Macarena
Organization:
Study Overview
Official Title:
Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies (BIO-FAST)
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIO-FAST
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: