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

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

Recruiting
18 years and older
All
Phase N/A

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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.

Eligibility

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.

Study details
    Stroke
    Acute

NCT03364296

Central Hospital, Nancy, France

29 May 2024

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