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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04726839
Other study ID # APHP200188
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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