StrokeBIO-FASTNCT04612218
Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies
An observational study of Stroke and Ischemic Stroke, run by Hospital Universitario Virgen Macarena at 4 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
- How many people
- 176 participants
- Where
- 4 sitesSpain
- Study dates
- 8 Nov 2019to 28 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital de Alta Resolución Sierra Norte
Seville
Hospital San Juan de Dios Aljarafe
Seville
Hospital Universitario Virgen del Rocío
Seville
Hospital Universitario Virgen Macarena
Seville
About this study
Official title: 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.
- Conditions
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
- Keywords
- blood biomarkers, stroke diagnosis, stroke, biomarkers, reperfusion therapies, acute stroke therapy, prehospital stroke management
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 2 years
Reperfusion rates
Measured: through study completion, an average of 2 years
Times to reperfusion
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start8 Nov 2019
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen Macarena
- Sponsor type
- University, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío, Hospital Alta Resolución Sierra Norte, Hospital San Juan de Dios Aljarafe, Hospital Universitario Reina Sofia de Cordoba
- Responsible party
- Principal investigator, Joan Montaner Villalonga, Hospital Universitario Virgen Macarena
- Investigators
- Joan Montaner, PhD, Study chair, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612218
- Sponsor's protocol ID
- BIO-FAST
- Acronym
- BIO-FAST
- Status last verified
- Aug 2021
- First submitted
- 23 Oct 2020
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies (BIO-FAST)
- ClinicalTrials.gov ID
- NCT04612218
- Acronym / sponsor ID
- BIO-FAST / BIO-FAST
- Conditions
- Stroke, Ischemic Stroke, Hemorrhagic Stroke
- Keywords
- blood biomarkers, stroke diagnosis, stroke, biomarkers, reperfusion therapies, acute stroke therapy, prehospital stroke management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Hospital Universitario Virgen MacarenaUniversity, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío, Hospital Alta Resolución Sierra Norte, Hospital San Juan de Dios Aljarafe, Hospital Universitario Reina Sofia de Cordoba
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Montaner, PhD study chair
Hospital Universitario Virgen Macarena
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Ischemic Stroke, run by Hospital Universitario Virgen Macarena at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke subtype diagnostic accuracy (time frame: through study completion, an average of 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.