Biomarkers algOrithm for strOke diagnoSis and Treatment Resistance Prediction

NCT04726839 | Completed

• 1 other identifier: APHP200188
• Study Type: observational
• Target: 3,880
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

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

  within 24 hours following inclusion

Secondary Outcomes (5)

• 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

• reperfusion therapy resistance (i.e. IV thrombolysis, MT)

  within 24 hours following inclusion

• cardio-embolic origin

  at 3 months

• Early neurological improvement

  at day 1 after inclusion

• Functional outcome

  at day 90 after inclusion

Study Arms (1)

Stroke suspicion

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

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

Interventions

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

Stroke suspicion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Symptoms consistent with stroke \<24 hours
• Adult patients ≥ 18 years old

You may not qualify if:

• Patient under guardianship or curatorship

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (4)

Department Neurology Caen Hospital

Caen, France

Location

Lariboisière

Paris, 75010, France

Location

Rothschild Foundation Hospital

Paris, France

Location

Hospital Foch

Suresnes, France

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

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

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: January 27, 2021
• Study Start: March 12, 2021
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

FR (4)