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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

930 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2025-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke, Acute

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients hospitalized for stroke

Group Type OTHER

Blood Samples

Intervention Type OTHER

Blood sample retrieved for biological assessment and biobanking

Interventions

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Blood Samples

Blood sample retrieved for biological assessment and biobanking

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No