Biomarkers algOrithm for strOke diagnoSis and Treatment Resistance Prediction (BOOST)

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 3946

Contacts and Locations

• Study Contact: Name: Mikael Mazighi; Phone Number: +331 48 03 67 03; Email: mikael.mazighi@aphp.fr
• Study Contact Backup: Name: Matthieu Resche-Rigon; Email: matthieu.resche-rigon@u-paris.fr

Study Locations

• France
  • Caen, France
    • Not yet recruiting
    • Department Neurology Caen Hospital
    • Contact: Emmanuel Touzé
  • Paris, France, 75010
    • Recruiting
    • Lariboisiere
    • Contact: Mikael Mazighi, Pr; Email: mikael.mazighi@aphp.fr
  • Paris, France
    • Recruiting
    • Rothschild Foundation Hospital
    • Contact: Mazighi Mikael
  • Suresnes, France
    • Not yet recruiting
    • Hospital Foch
    • Contact: Bertrand LAPERGUE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnosis by the selected panel of blood biomarkers of the LVO presence eligible for MT	within 24 hours following inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	at day 1 after inclusion
Functional outcome	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.	at day 90 after inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2021
• Primary Completion (Anticipated): March 1, 2025
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: January 24, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: APHP200188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No