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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04612218
Recruitment Status : Completed
First Posted : November 2, 2020
Last Update Posted : August 26, 2021
Sponsor:
Collaborators:
Hospitales Universitarios Virgen del Rocío
Hospital Alta Resolución Sierra Norte
Hospital San Juan de Dios Aljarafe
Hospital Universitario Reina Sofia de Cordoba
Information provided by (Responsible Party):
Joan Montaner Villalonga, Hospital Universitario Virgen Macarena

Study Description
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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.

Condition or disease
Stroke Ischemic Stroke Hemorrhagic Stroke

Study Design
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Study Type : Observational
Actual Enrollment : 176 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies (BIO-FAST)
Actual Study Start Date : November 8, 2019
Actual Primary Completion Date : July 28, 2021
Actual Study Completion Date : July 28, 2021
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Reperfusion rates [ Time Frame: through study completion, an average of 2 years ]
  3. Times to reperfusion [ Time Frame: through study completion, an average of 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04612218


Locations
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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, Spain
Sponsors and Collaborators
Hospital Universitario Virgen Macarena
Hospitales Universitarios Virgen del Rocío
Hospital Alta Resolución Sierra Norte
Hospital San Juan de Dios Aljarafe
Hospital Universitario Reina Sofia de Cordoba
Investigators
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Study Chair: Joan Montaner, PhD Hospital Universitario Virgen Macarena
More Information
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Responsible Party: Joan Montaner Villalonga, Head Department of Neurology, Hospital Universitario Virgen Macarena
ClinicalTrials.gov Identifier: NCT04612218    
Other Study ID Numbers: BIO-FAST
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joan Montaner Villalonga, Hospital Universitario Virgen Macarena:
blood biomarkers
stroke diagnosis
stroke
biomarkers
 reperfusion therapies
acute stroke therapy
prehospital stroke management
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Hemorrhagic Stroke
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases