Biomarkers algOrithm for strOke diagnoSis and Treatment Resistance Prediction

NCT ID: NCT04726839

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3880 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-12
• Study Completion Date: 2025-07-10

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.

Conditions

Stroke, Ischemic; Large Vessel Occlusion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Stroke suspicion

Patients with stroke suspicion within 24 hours of stroke's symptoms

Standard of care for stroke management and evaluation of functionnal outcome at 3 months

Intervention Type: OTHER

Additional tubes at inclusion (maximum 13 mL) Collection of the mRS data during a routine visit if planned at 3 months +/-15 days or, if not during a specific research phone call at 3 months

Interventions

Standard of care for stroke management and evaluation of functionnal outcome at 3 months

Additional tubes at inclusion (maximum 13 mL) Collection of the mRS data during a routine visit if planned at 3 months +/-15 days or, if not during a specific research phone call at 3 months

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department Neurology Caen Hospital

Caen, , France

Lariboisière

Paris, , France

Rothschild Foundation Hospital

Paris, , France

Hospital Foch

Suresnes, , France

Countries

France

Other Identifiers

APHP200188

Identifier Type: -

Identifier Source: org_study_id