NCT05833945

Brief Summary

Stroke is the leading cause of long-term disability and the second most common cause of death worldwide. Currently, the protocols require the imaging techniques at the hospitals to differ ischemic strokes with large vessel occlusion (LVO) from others. In this study, a duplex POC will be used in combination with an APP to identify LVO ischemic strokes in a 800 patients'cohort with pre-hospital and in-hospital blood samples.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
355

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

16 active sites

Status
completed

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

First Submitted

Initial submission to the registry

April 5, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

April 15, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2024

Completed
Last Updated

November 18, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

April 5, 2023

Last Update Submit

November 14, 2024

Conditions

Stroke, Acute Ischemic

Keywords

Large Vessels Occlusion (LVO)ThrombectomyBiomarkersPoint of care test (POCT)

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the diagnosis accuracy of the algorithm LVOCheck (Specificity and sensibility)

    * Biomarkers * Clinical data (gender, age, diabetes, dyslipidemia, atrial fibrillation, blood pressure) * Neurologic scales (NIHSS, RACE, GFAST, Cincinatti)

    6 months

Secondary Outcomes (1)

  • Viability of the implement of the tool at a pre-hospital environment

    6 months

Study Arms (1)

Pre-hospital and in-hospital patients

Patients recruited at the ambulance (ARM A) and at the hospital (ARM B).

Device: Large Vessel Occlusion Biomarkers Test

Interventions

Large Vessel Occlusion Biomarkers TestDEVICE

Duplex Point of Care test to measure the concentration of biomarkers associated to Large Vessel Occlusion in blood samples used in combination with an APP.

Pre-hospital and in-hospital patients

Eligibility Criteria

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

Patients with stroke code activated will be recruited at a pre-hospital and hospital environment.

You may qualify if:

  • I.1: Patients \> 18 years old.
  • I.2: Stroke code activated.
  • 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.

You may not qualify if:

  • E.1: Previous diagnosis different from stroke.
  • E.2: Impossibility of getting a blood sample.
  • E.3: Refusal to provide the informed consent by the patient/relative.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Complejo Hospitalario Universitario Albacete

Albacete, Spain

Location

Hospital Universitario Poniente

Almería, Spain

Location

Hospital Universitario Torrecárdenas

Almería, Spain

Location

Hospital General San Jorge

Huesca, Spain

Location

Hospital San Pedro

Logroño, Spain

Location

Hospital General Río Carrión

Palencia, Spain

Location

Hospital General de Segovia

Segovia, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

Hospital Universitario Virgen Rocío

Seville, Spain

Location

Hospital La Fe

Valencia, Spain

Location

Hospital Clínico de Valladolid

Valladolid, Spain

Location

Hospital de Medina del Campo

Valladolid, Spain

Location

Hospital Universitario Río Hortega

Valladolid, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Location

Hospital Miguel Servet

Zaragoza, Spain

Location

Hospital Royo Villanova

Zaragoza, Spain

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ana Barragán Prieto

    Hospital Universitario Virgen Macarena

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 5, 2023

First Posted

April 27, 2023

Study Start

April 15, 2023

Primary Completion

January 31, 2024

Study Completion

April 24, 2024

Last Updated

November 18, 2024

Record last verified: 2024-09

Locations

ES(16)