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Clinical Trials/NCT04726839
NCT04726839
Completed
Not Applicable

Biomarkers algOrithm for strOke diagnoSis and Treatment Resistance Prediction

Assistance Publique - Hôpitaux de Paris4 sites in 1 country3,880 target enrollmentMarch 12, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke, Ischemic
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
3880
Locations
4
Primary Endpoint
Diagnosis by the selected panel of blood biomarkers of the LVO presence eligible for MT
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

Triage of acute ischemic stroke (AIS) patients is critical, to decrease time to treatment, and improve functional outcome. The therapeutic standard of care for AIS consecutive to large vessel occlusion (LVO) is the association of intravenous (IV) alteplase administration and mechanical thrombectomy (MT). However, there are limited places where MT can be performed. Therefore, there is a need for innovative tools to identify, in the ambulance, patients with LVO that require MT. Sending the patients at the right, avoiding futile stops (i.e. in places where MT is not available), is definitively a strategy that saves time.

There is currently no biomarker nor Point Of Care (POC) Lab Testing to solve this issue and clinical scoring methods such as the NIHSS have a low accuracy rate to detect LVO. The relevance of blood biomarkers for LVO diagnosis and therapeutic decisions needs to be confirmed for effective triage in the setting of AIS with LVO, which represent 30% of all AIS.

The main objective of our study is to determine diagnostic performances of a panel of selected blood biomarkers to identify patients with AIS consecutive to LVO among those with stroke suspicion, within 24 hours of stroke symptom's onset before brain imaging.

This could facilitate the triage of patients with LVO refractory to thrombolysis treatment, who may benefit most from MT.

Registry
clinicaltrials.gov
Start Date
March 12, 2021
End Date
July 10, 2025
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Symptoms consistent with stroke \<24 hours
  • Adult patients ≥ 18 years old
  • Non opposition of the patient or his/her relatives to the research (emergency inclusion procedure)

Exclusion Criteria

  • Patient under guardianship or curatorship

Outcomes

Primary Outcomes

Diagnosis by the selected panel of blood biomarkers of the LVO presence eligible for MT

Time Frame: within 24 hours following inclusion

Secondary Outcomes

  • Discrimination by the selected panel of blood biomarkers of LVO from small strokes, and AIS from hemorrhagic strokes and stroke mimics(within 24 hours following inclusion)
  • Functional outcome(at day 90 after inclusion)
  • Early neurological improvement(at day 1 after inclusion)
  • reperfusion therapy resistance (i.e. IV thrombolysis, MT)(within 24 hours following inclusion)
  • cardio-embolic origin(at 3 months)

Study Sites (4)

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