Biomarkers algOrithm for strOke diagnoSis and Treatment Resistance Prediction

Stroke, Ischemic Clinical Trial

— BOOST  

Official title:

Biomarkers algOrithm for strOke diagnoSis and Treatment Resistance Prediction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04726839
• Other study ID #: APHP200188
• Status: Recruiting
• Start date: March 12, 2021
• Est. completion date: March 2025

Study information

• Verified date: June 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Mikael Mazighi
• Phone: +331 48 03 67 03
• Email: mikael.mazighi[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3946
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Large Vessel Occlusion
• Stroke
• Stroke, Ischemic

Intervention

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

Locations

Country	Name	City	State
France	Department Neurology Caen Hospital	Caen
France	Lariboisière	Paris
France	Rothschild Foundation Hospital	Paris
France	Hospital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis by the selected panel of blood biomarkers of the LVO presence eligible for MT		within 24 hours following inclusion
Secondary	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
Secondary	reperfusion therapy resistance (i.e. IV thrombolysis, MT)		within 24 hours following inclusion
Secondary	cardio-embolic origin		at 3 months
Secondary	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
Secondary	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