Status:
RECRUITING
Biological Dating of Cerebral Ischemia With GST-π/PRDX1 to Detect Patients With Stroke of Unknown Onset Within the Therapeutic Window of Thrombolysis
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Stroke, Acute
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 populati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
930 Patients enrolled
Trial Details
Trial ID
NCT03364296
Start Date
October 15 2018
End Date
March 1 2025
Last Update
May 17 2024
Active Locations (5)
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1
Centre Hospitalier de Bar-Le-Duc
Bar-le-Duc, France, 55000
2
Hôpital Central
Nancy, France, 54000
3
Fondation Adolphe de Rothschild
Paris, France, 75019
4
Centre Hospitalier de Troyes
Troyes, France, 10003