NCT04612218

Brief Summary

Stroke is the first cause of death among Spanish women and main cause of disability. Reperfusion therapies of the occluded artery remain the only useful approach in acute ischemic stroke. However, the efficacy of these strategies is highly time-dependent and due to the need of neuroimaging (CT or MRI) to differentiate between ischemic and hemorrhagic stroke, impossible to be performed at the pre-hospital level. The investigators aim to set-up a point of-care (POC) device to validate a biomarker panel differentiating ischemic and hemorrhagic stroke at the pre-hospital level using a blood sample and to validate a second biomarker panel for the early identification of patients with large vessel occlusions (LVO), which are candidates for mechanical thrombectomy. For that, the investigators will recruit a 300 patients' cohort with pre-hospital blood samples using available POCs for each of those markers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

4 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

Study Start

First participant enrolled

November 8, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2021

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

1.7 years

First QC Date

October 23, 2020

Last Update Submit

August 25, 2021

Conditions

StrokeIschemic StrokeHemorrhagic Stroke

Keywords

blood biomarkersstroke diagnosisstrokebiomarkersreperfusion therapiesacute stroke therapyprehospital stroke management

Outcome Measures

Primary Outcomes (3)

  • Stroke subtype diagnostic accuracy

    Stroke subtype diagnostic (% ischemic versus % hemorrhagic and % stroke mimics) will be determined by clinical and neuroimaging criteria at hospital arrival and compared with diagnostic accuracy of a blood biomarkers based test

    through study completion, an average of 2 years

  • Reperfusion rates

    through study completion, an average of 2 years

  • Times to reperfusion

    through study completion, an average of 2 years

Eligibility Criteria

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

Patients older than 18 years old, in whom health care services activate a stroke code, and the patient is transferred to the reference centre, within 6 hours from symptoms onset.

You may qualify if:

  • I.1: Patients \> 18 years old.
  • I.2: Stroke code activated by the coordinator centre.
  • 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: Prehospital diagnosis different of stroke.
  • E.2: Impossibility of getting a prehospital 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 (4)

Hospital de Alta Resolución Sierra Norte

Seville, Spain

Location

Hospital San Juan de Dios Aljarafe

Seville, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Spain

Location

MeSH Terms

Conditions

StrokeIschemic StrokeHemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Joan Montaner, PhD

    Hospital Universitario Virgen Macarena

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Department of Neurology

Study Record Dates

First Submitted

October 23, 2020

First Posted

November 2, 2020

Study Start

November 8, 2019

Primary Completion

July 28, 2021

Study Completion

July 28, 2021

Last Updated

August 26, 2021

Record last verified: 2021-08

Locations

ES(4)