Clinical trial NCT04726839: Biomarkers algOrithm for strOke diagnoSis and Treatment Resistance Prediction
Official title: Biomarkers algOrithm for strOke diagnoSis and Treatment Resistance Prediction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke, Ischemic
Large Vessel Occlusion
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 3946
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stroke suspicion within 24 hours of stroke's symptoms

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.


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

Primary outcomes:
measure: Diagnosis by the selected panel of blood biomarkers of the LVO presence eligible for MT
timeFrame: within 24 hours following inclusion
Secondary outcomes:
measure: Discrimination by the selected panel of blood biomarkers of LVO from small strokes, and AIS from hemorrhagic strokes and stroke mimics
timeFrame: within 24 hours following inclusion
measure: reperfusion therapy resistance (i.e. IV thrombolysis, MT)
timeFrame: within 24 hours following inclusion
measure: cardio-embolic origin
timeFrame: at 3 months
measure: Early neurological improvement
timeFrame: at day 1 after inclusion
measure: Functional outcome
timeFrame: at day 90 after inclusion
Other outcomes:
Locations:
city: Caen
country: France
facility: Department Neurology Caen Hospital
city: Paris
country: France
facility: Lariboisière
city: Paris
country: France
facility: Rothschild Foundation Hospital
city: Suresnes
country: France
facility: Hospital Foch
Study officials:
References: