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Clinical Trials/NCT06467396
NCT06467396
Recruiting
Not Applicable

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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla2 sites in 1 country400 target enrollmentApril 9, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Ischemic Stroke
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Enrollment
400
Locations
2
Primary Endpoint
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).
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 9, 2024
End Date
July 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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).

Time Frame: through the study completion, an average of one year

Secondary Outcomes

  • Percentage of patients who suffer a futile recanalization after a mechanical thrombectomy.(3 months)

Study Sites (2)

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