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

Last updated: May 16, 2024
Sponsor: Central Hospital, Nancy, France
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Occlusions

Cerebral Ischemia

Treatment

Blood Samples

Clinical Study ID

NCT03364296
PHRCI 2016/FLAG1 - RICHARD /MS
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients over 18 years old

  • Patients with symptoms consistent with stroke and a National Institute of HealthStroke 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 ofsymptom 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 ofprecise time of symptom onset is not required. For these patients, to ensureonset-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

Exclusion Criteria:

  • Persons referred in articles L.1121-5, L.1121-7, L.1121-8 and L.1122-2 of the FrenchPublic Health Code: Pregnant, parturient or breastfeeding woman ; Minor person (non-emancipated) ; Adult person under legal protection (any form of publicguardianship) ; Adult person incapable of giving consent and not under legalprotection.

  • Persons deprived of liberty for judicial or administrative decision.

  • Persons subject to psychiatric care under articles L.3212-1 and L.3213-1 of theFrench Public Health Code.

  • Known cancer in progression.

  • Known cirrhosis.

  • Myocardial Infarctions, stroke, Subarachnoid hemorrhage or intracranial injurywithin 3 months prior to enrolment.

Study Design

Total Participants: 930
Treatment Group(s): 1
Primary Treatment: Blood Samples
Phase:
Study Start date:
October 15, 2018
Estimated Completion Date:
March 01, 2025

Connect with a study center

  • Centre Hospitalier de Bar-Le-Duc

    Bar-le-Duc, 55000
    France

    Active - Recruiting

  • Hôpital de Mercy

    Metz, 57245
    France

    Site Not Available

  • Hôpital Central

    Nancy, 54000
    France

    Active - Recruiting

  • Fondation Adolphe de Rothschild

    Paris, 75019
    France

    Active - Recruiting

  • Centre Hospitalier de Troyes

    Troyes, 10003
    France

    Active - Recruiting

  • Centre Hospitalier de Verdun

    Verdun, 55300
    France

    Active - Recruiting

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