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

August 25, 2021 updated by: Joan Montaner Villalonga, Hospital Universitario Virgen Macarena

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Sevilla, Spain
        • Hospital Universitario Virgen del Rocio
      • Sevilla, Spain
        • Hospital Universitario Virgen Macarena
      • Sevilla, Spain
        • Hospital de Alta Resolución Sierra Norte
      • Sevilla, Spain
        • Hospital San Juan de Dios Aljarafe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients older than 18 years old, in whom health care services activate a stroke code, and the patient is transferred to the reference centre, within 6 hours from symptoms onset.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 2 years
Reperfusion rates
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years
Times to reperfusion
Time Frame: through study completion, an average of 2 years
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Virgen Macarena

Collaborators

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

Investigators

  • Study Chair: Joan Montaner, PhD, Hospital Universitario Virgen Macarena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 8, 2019

Primary Completion (ACTUAL)

July 28, 2021

Study Completion (ACTUAL)

July 28, 2021

Study Registration Dates

First Submitted

October 23, 2020

First Submitted That Met QC Criteria

October 30, 2020

First Posted (ACTUAL)

November 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO-FAST

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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