Biological Dating of Cerebral Ischemia With GST-π/PRDX1 to Detect Patients With Stroke of Unknown Onset Within the Therapeutic Window of Thrombolysis

Central Hospital, Nancy, France930 enrolled

Overview

The FLAG1 study will assess the diagnostic performance of biomarkers Glutathion S-Transferase-π (GST-π) and Peroxyredoxin 1 (PRDX1) to identify cerebral infarction of less than 4,5 hours in a population of patients with neurological deficiency of less than 12 hours.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

930

Conditions

Stroke, Acute

Interventions

Blood SamplesOTHER

Blood sample retrieved for biological assessment and biobanking

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients over 18 years old * Patients with symptoms consistent with stroke and a National Institute of Health Stroke Score ≥3 at the inclusion time * Time symptom onset ≤ 24 hours at inclusion: * For patients with time of symptom onset is \<4.5h at inclusion, the time of symptom onset has to be precisely known, with a margin of error not exceeding 30 minutes (through patient or witness interview) * For patients with time of symptom onset is \>4.5h at inclusion, knowledge of precise time of symptom onset is not required. For these patients, to ensure onset-to-inclusion time is between 4.5 and 24 hours at inclusion: * last time patient presented no deficit must be less than 24 hours, * symptoms must have been first recognized more than 4.5 hours before blood draw. * Possibility to perform MRI within the 30 minutes following blood collection * Person affiliated to or beneficiary of a social security plan Exclusion Criteria: * Persons referred in articles L.1121-5, L.1121-7, L.1121-8 and L.1122-2 of the French Public Health Code: Pregnant, parturient or breastfeeding woman ; Minor person (non-emancipated) ; Adult person under legal protection (any form of public guardianship) ; Adult person incapable of giving consent and not under legal protection. * Persons deprived of liberty for judicial or administrative decision. * Persons subject to psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code. * Known cancer in progression. * Known cirrhosis. * Myocardial Infarctions, stroke, Subarachnoid hemorrhage or intracranial injury within 3 months prior to enrolment.

Locations (5)

Centre Hospitalier de Bar-Le-Duc

Bar-le-Duc, France

RECRUITING

Hôpital Central

Nancy, France

RECRUITING

Fondation Adolphe de Rothschild

Paris, France

RECRUITING

Outcomes

Primary Outcomes

Time (<4.5 hours) between cerebral infarction onset and blood sample for determination for GST-π level

ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π plasmatic level to identify cerebral infarction of less than 4.5 hours.

Time frame: Population will be dichotomized in patients with blood sample performed <4.5 hours and >4.5 hours after stroke onset to determine diagnostic performance of GST-π plasmatic level to identify cerebral infarction of less than 4.5 hours.

Time (<4.5 hours) between cerebral infarction onset and blood sample for determination for PRDX1 levels

ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of PRDX1 plasmatic level to identify cerebral infarction of less than 4.5 hours.

Time frame: Population will be dichotomized in patients with blood sample performed <4.5 hours and >4.5 hours after stroke onset to determine diagnostic performance of PRDX1 plasmatic level to identify cerebral infarction of less than 4.5 hours

Secondary Outcomes

Time (<3 and 6 hours) between cerebral infarction onset and blood sample for determination for GST-π and PRDX1 levels

ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π and PRDX1 plasmatic levels to identify cerebral infarction of less than 3 and 6 hours.

Time frame: Patient will be dichotomized with blood sample performed <3 and >3 hours, and <6 and >6 hours after stoke onset to determine diagnostic performance of GST-π and PRDX1 plasmatic levels to identify cerebral infarction of less than 3 hours, and < 6 hours

Blood sample for determination for GST-π and PRDX1 levels Cerebral MRI for Diffusion/Perfusion mismatch defining ischemic penumbra

ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π and PRDX1 plasmatic levels to identify and quantify ischemic penumbra.

Time frame: The patient will be included within the 12 hours following stroke onset with one blood sample (defining GST-π and PRDX1 plasmatic levels), and cerebral MRI (defining Diffusion/Perfusion mismatch or penumbra) within the 30 minutes following blood sample.

Central Contacts

Sébastien RICHARD, MD

CONTACT

0033383852256 s.richard@chru-nancy.fr

Sanae BOUALI, PhD

CONTACT

s.bouali@chru-nancy.fr

Data from ClinicalTrials.gov

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