Blood Biomarkers to Predict the Prognosis of a Stroke Patient Undergoing Mechanical Thrombectomy

NCT ID: NCT06467396

Last Updated: 2024-06-21

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

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-09

Study Completion Date

2025-07-31

Brief Summary

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The goal of this observational study is to evaluate the accuracy of a panel of blood biomarkers and clinical variables in predicting the prognosis of stroke patients treated by mechanical thrombectomy, specifically to predict futile recanalization and mortality.

Detailed Description

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Stroke is the leading cause of long-term disability and the second most common cause of death worldwide, accounting for around 6.7 million deaths each year. The burden of stroke due to illness, disability and early death is set to double within the next 15 years due to an ageing population. The socio-economical cost of the stroke is very high, being around 45 million euros per year in Europe. Although mechanical thrombectomy is the most effective treatment for stroke patients with large vessel occlusions still a large percentage of patients, around 50%, do not recover despite a successful recanalization (the so called "futile recanalization"). Therefore, to anticipate the prognosis of patients treated with mechanical thrombectomy would be clinically relevant and very informative.

This observational study evaluates the precision of a rapid test of blood biomarkers in the prognosis of stroke patients treated by mechanical thrombectomy. For that, the investigators will recruit a cohort of 400 consecutive patients treated by thrombectomy. Using a multiplex POC for the biomarker measurement and an APP in combination with clinical data, the potential of biomarkers to predict the prognosis of a patient will be determined.

Conditions

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Acute Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Large Vessel Occlusion Biomarkers Test

Duplex Point of Care test to measure the concentration of blood biomarkers (FABP+NT-proBNP) associated to Large Vessel Occlusion in blood samples used in combination with an APP.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients \> 18 years old.
* Patient in whom a mechanical thrombectomy is performed.

Exclusion Criteria

* Impossibility of getting a blood sample.
* Impossibility of performing the test (Invalid results)
* 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 Universitario Reina Sofia de Cordoba

OTHER_GOV

Sponsor Role collaborator

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario Reina Sofía

Córdoba, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Rocío

Seville, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Rosa M Delgado

Role: CONTACT

955923067

Carmen De Jesús Gil

Role: CONTACT

955923067

Facility Contacts

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Fernando Delgado Acosta

Role: primary

Alejandro González García

Role: primary

Other Identifiers

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TROMBOPOCT

Identifier Type: -

Identifier Source: org_study_id

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