Biological Dating of Cerebral Ischemia With GST-π/PRDX1 to Detect Patients With Stroke of Unknown Onset Within the Therapeutic Window of Thrombolysis (FLAG1)

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Stroke, Acute

Treatments: Other: Blood Samples

Study type: Interventional

Funder types: Other

Identifiers

NCT03364296

PHRCI 2016/FLAG1 - RICHARD /MS

Details and patient eligibility

About

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.

Enrollment: 930 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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930 participants in 1 patient group

Patients hospitalized for stroke

Other group

Treatment:

Other: Blood Samples