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NCT03364296Completed

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 Glutathion S-Transferase-π (GST-π) and Peroxyredoxin 1 (PRDX1) to Detect Patients With Stroke of Unknown Onset Within the Therapeutic Window of Thrombolysis

Source: ClinicalTrials.gov · Last updated 25 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
935 (actual)
First submitted
23 Nov 2017
Start date
15 Oct 2018
Primary completion date
2 Dec 2024
Lead sponsor
Central Hospital, Nancy, France
Diseases
Stroke
NCT number
NCT03364296

What you commit to

  • Study type: Interventional
  • Participants enrolled: 935
  • From 15 Oct 2018 to the primary completion date, 2 Dec 2024
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • Persons subject to psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code.
  • Known cancer in progression.

Other

  • 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.
  • Known cirrhosis.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier de Bar-Le-Duc
Coordinator of this site? Confirm its status
Bar-le-DucFranceUnknown status
Hôpital Central,
Coordinator of this site? Confirm its status
NancyFranceUnknown status
Fondation Adolphe de Rothschild
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Centre Hospitalier de Troyes
Coordinator of this site? Confirm its status
TroyesFranceUnknown status
Centre Hospitalier de Verdun
Coordinator of this site? Confirm its status
VerdunFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.