NCT03364296

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 population of patients with neurological deficiency of less than 12 hours.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
930

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

5.9 years

First QC Date

November 23, 2017

Last Update Submit

May 16, 2024

Conditions

Stroke, Acute

Keywords

Acute stroke, Biomarkers

Outcome Measures

Primary Outcomes (2)

  • Time (<4.5 hours) between cerebral infarction onset and blood sample for determination for GST-π level

    ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π plasmatic level to identify cerebral infarction of less than 4.5 hours.

    Population will be dichotomized in patients with blood sample performed <4.5 hours and >4.5 hours after stroke onset to determine diagnostic performance of GST-π plasmatic level to identify cerebral infarction of less than 4.5 hours.

  • Time (<4.5 hours) between cerebral infarction onset and blood sample for determination for PRDX1 levels

    ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of PRDX1 plasmatic level to identify cerebral infarction of less than 4.5 hours.

    Population will be dichotomized in patients with blood sample performed <4.5 hours and >4.5 hours after stroke onset to determine diagnostic performance of PRDX1 plasmatic level to identify cerebral infarction of less than 4.5 hours

Secondary Outcomes (7)

  • Time (<3 and 6 hours) between cerebral infarction onset and blood sample for determination for GST-π and PRDX1 levels

    Patient will be dichotomized with blood sample performed <3 and >3 hours, and <6 and >6 hours after stoke onset to determine diagnostic performance of GST-π and PRDX1 plasmatic levels to identify cerebral infarction of less than 3 hours, and < 6 hours

  • Blood sample for determination for GST-π and PRDX1 levels Cerebral MRI for Diffusion/Perfusion mismatch defining ischemic penumbra

    The patient will be included within the 12 hours following stroke onset with one blood sample (defining GST-π and PRDX1 plasmatic levels), and cerebral MRI (defining Diffusion/Perfusion mismatch or penumbra) within the 30 minutes following blood sample.

  • Blood sample for determination for GST-π and PRDX1 levels Cerebral MRI for diagnosis of stroke vs. other diagnosis

    The patient will be included within the 12 hours following neurological deficiency onset with one blood sample (defining GST-π and PRDX1 plasmatic levels), and cerebral MRI (defining stroke) within the 30 minutes following blood sample.

  • Blood sample for determination for GST-π and PRDX1 levels Cerebral MRI for diagnosis of ischemic stroke vs. other diagnosis

    The patient will be included within the 12 hours following neurological deficiency onset with one blood sample (defining GST-π and PRDX1 plasmatic levels), and cerebral MRI (defining stroke) within the 30 minutes following blood sample.

  • Blood sample for determination for GST-π and PRDX1 levels Cerebral MRI for diagnosis of hemorrhagic stroke vs. other diagnosis

    The patient will be included within the 12 hours following neurological deficiency onset with one blood sample (defining GST-π and PRDX1 plasmatic levels), and cerebral MRI (defining stroke) within the 30 minutes following blood sample.

  • +2 more secondary outcomes

Study Arms (1)

Patients hospitalized for stroke

OTHER
Other: Blood Samples

Interventions

Blood SamplesOTHER

Blood sample retrieved for biological assessment and biobanking

Patients hospitalized for stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years old
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre Hospitalier de Bar-Le-Duc

Bar-le-Duc, 55000, France

RECRUITING

Hôpital Central

Nancy, 54000, France

RECRUITING

Fondation Adolphe de Rothschild

Paris, 75019, France

RECRUITING

Centre Hospitalier de Troyes

Troyes, 10003, France

RECRUITING

Centre Hospitalier de Verdun

Verdun, 55300, France

RECRUITING

Related Publications (1)

  • Karakus A, Girerd N, Sanchez JC, Sabben C, Wietrich A, Lavandier K, Marchal S, Aubertin A, Humbertjean L, Mione G, Bouali S, Duarte K, Reymond S, Gory B, Richard S. Identifying patients with cerebral infarction within the time window compatible with reperfusion therapy, diagnostic performance of glutathione S-transferase-pi (GST-pi) and peroxiredoxin 1 (PRDX1): exploratory prospective multicentre study FLAG-1 protocol. BMJ Open. 2021 Aug 20;11(8):e046167. doi: 10.1136/bmjopen-2020-046167.

    PMID: 34417212DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Sébastien RICHARD, MD

CONTACT

0033383852256s.richard@chru-nancy.fr

Sanae BOUALI, PhD

CONTACT

s.bouali@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 23, 2017

First Posted

December 6, 2017

Study Start

October 15, 2018

Primary Completion

September 13, 2024

Study Completion

March 1, 2025

Last Updated

May 17, 2024

Record last verified: 2024-05

Locations

FR(5)