NCT06467396

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

June 21, 2024

Status Verified

May 1, 2024

Enrollment Period

12 months

First QC Date

June 14, 2024

Last Update Submit

June 20, 2024

Conditions

Keywords

Large Vessel Occlusion Biomarkers TestThrombectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Percentage of patients who suffer a futile recanalization after a mechanical thrombectomy.

    3 months

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stroke patients with large vessel occlusion treated by mechanical thrombectomy

You may qualify if:

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

You may not qualify if:

  • Impossibility of getting a blood sample.
  • Impossibility of performing the test (Invalid results)
  • Refusal to provide the informed consent by the patient/relative.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario Reina Sofía

Córdoba, Spain

RECRUITING

Hospital Universitario Virgen Rocío

Seville, Spain

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Carmen De Jesús Gil

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2024

First Posted

June 21, 2024

Study Start

April 9, 2024

Primary Completion

April 1, 2025

Study Completion

July 1, 2025

Last Updated

June 21, 2024

Record last verified: 2024-05

Locations