Biomarkers algOrithm for strOke diagnoSis and Treatment Resistance Prediction

Recruiting

• Conditions: Stroke, Ischemic; Large Vessel Occlusion
• Interventions: Other: Standard of care for stroke management and evaluation of functionnal outcome at 3 months

• Registration Number: NCT04726839
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-24
• Study First Submitted QC: 2021-01-24
• Study First Posted: 2021-01-27
• Study Start: 2021-03-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-23
• Last Update Posted: 2021-06-24
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3946

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stroke suspicion	Standard of care for stroke management and evaluation of functionnal outcome at 3 months	Patients with stroke suspicion within 24 hours of stroke's symptoms

Primary Outcome Measures

Name	Time	Method
Diagnosis by the selected panel of blood biomarkers of the LVO presence eligible for MT	within 24 hours following inclusion

Secondary Outcome Measures

Name	Time	Method
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	Functional outcome will be assessed by modified Rankin Scale (mRS); It consists of a single item, with 6 levels of disability. 0 corresponding to no disability, and five to severe disability.
Early neurological improvement	at day 1 after inclusion	Early neurological improvement will be assessed by NIHSS. Early neurological improvement will be defined as decrease of 8 points in the NIHSS or a NIHSS 0-1 within 24h for LVO confirmed patients
reperfusion therapy resistance (i.e. IV thrombolysis, MT)	within 24 hours following inclusion
cardio-embolic origin	at 3 months

Trial Locations

Locations (4)

Hospital Foch; 🇫🇷 Suresnes, France

Lariboisière; 🇫🇷 Paris, France

Department Neurology Caen Hospital; 🇫🇷 Caen, France

Rothschild Foundation Hospital; 🇫🇷 Paris, France