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

Recruiting

• Conditions: Acute Ischemic Stroke

• Registration Number: NCT06467396
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief Summary

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

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.

Study Timeline

• Study Start: 2024-04-09
• Status Verified: 2024-05
• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-20
• Last Update Submitted: 2024-06-20
• Study First Posted: 2024-06-21
• Last Update Posted: 2024-06-21
• Primary Completion: 2025-04
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Specificity and sensibility of blood biomarkers in combination with neurological scales (NIHSS) determined before the thrombectomy intervention to predict the prognosis of the patient (functional dependence and mortality).	through the study completion, an average of one year

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who suffer a futile recanalization after a mechanical thrombectomy.	3 months

Trial Locations

Locations (2)

Hospital Universitario Virgen Rocío; 🇪🇸 Sevilla, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain