Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies

NCT ID: NCT04612218

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-08

Study Completion Date

2021-07-28

Brief Summary

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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

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Conditions

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Stroke Ischemic Stroke Hemorrhagic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospitales Universitarios Virgen del Rocío

OTHER

Sponsor Role collaborator

Hospital Alta Resolución Sierra Norte

UNKNOWN

Sponsor Role collaborator

Hospital San Juan de Dios Aljarafe

UNKNOWN

Sponsor Role collaborator

Hospital Universitario Reina Sofia de Cordoba

OTHER_GOV

Sponsor Role collaborator

Hospital Universitario Virgen Macarena

OTHER

Sponsor Role lead

Responsible Party

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Joan Montaner Villalonga

Head Department of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joan Montaner, PhD

Role: STUDY_CHAIR

Hospital Universitario Virgen Macarena

Locations

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Hospital de Alta Resolución Sierra Norte

Seville, , Spain

Site Status

Hospital San Juan de Dios Aljarafe

Seville, , Spain

Site Status

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status

Countries

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Spain

Other Identifiers

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BIO-FAST

Identifier Type: -

Identifier Source: org_study_id

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