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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 (FLAG1)

Primary Purpose

Stroke, Acute

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Blood Samples

About this trial

This is an interventional diagnostic trial for Stroke, Acute focused on measuring Acute stroke, Biomarkers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Centre Hospitalier de Bar-Le-DucRecruiting
Hôpital CentralRecruiting
Fondation Adolphe de RothschildRecruiting
Centre Hospitalier de TroyesRecruiting
Centre Hospitalier de VerdunRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients hospitalized for stroke

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π and PRDX1 plasmatic levels to identify cerebral infarction of less than 3 and 6 hours.

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

ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π and PRDX1 plasmatic levels to identify and quantify ischemic penumbra.

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

ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π and PRDX1 plasmatic levels to identify stroke.

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

ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π and PRDX1 plasmatic levels to identify cerebral infarction.

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

ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π and PRDX1 plasmatic levels to identify hemorrhagic stroke.

MRI Diffusion/FLAIR mismatch (yes versus no)

Volume of cerebral infarction assessed by MRI diffusion weighted imaging.

Full Information

NCT ID

NCT03364296

First Posted

November 23, 2017

Last Updated

June 27, 2022

Sponsor

Central Hospital, Nancy, France

1. Study Identification

Unique Protocol Identification Number

NCT03364296

Brief Title

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

Acronym

FLAG1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 15, 2018 (Actual)

Primary Completion Date

September 13, 2024 (Anticipated)

Study Completion Date

March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Acute

Keywords

Acute stroke, Biomarkers

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

930 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients hospitalized for stroke

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

Blood Samples

Intervention Description

Blood sample retrieved for biological assessment and biobanking

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

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.

Title

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

Description

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.

Time Frame

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 Outcome Measure Information:

Title

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

Description

ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π and PRDX1 plasmatic levels to identify cerebral infarction of less than 3 and 6 hours.

Time Frame

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

Title

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

Description

ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π and PRDX1 plasmatic levels to identify and quantify ischemic penumbra.

Time Frame

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.

Title

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

Description

ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π and PRDX1 plasmatic levels to identify stroke.

Time Frame

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.

Title

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

Description

ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π and PRDX1 plasmatic levels to identify cerebral infarction.

Time Frame

Title

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

Description

ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π and PRDX1 plasmatic levels to identify hemorrhagic stroke.

Time Frame

Title

MRI Diffusion/FLAIR mismatch (yes versus no)

Time Frame

Title

Volume of cerebral infarction assessed by MRI diffusion weighted imaging.

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sébastien RICHARD, MD

Phone

0033383852256

s.richard@chru-nancy.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Sanae BOUALI, PhD

s.bouali@chru-nancy.fr

Facility Information:

Facility Name

Centre Hospitalier de Bar-Le-Duc

City

Bar-le-Duc

ZIP/Postal Code

55000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karine LAVANDIER, MD

First Name & Middle Initial & Last Name & Degree

Karine LAVANDIER, MD

Facility Name

Hôpital Central

City

Nancy

ZIP/Postal Code

54000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sébastien RICHARD, Professor

s.richard@chru-nancy.fr

First Name & Middle Initial & Last Name & Degree

Sébastien RICHARD, Professor

Facility Name

Fondation Adolphe de Rothschild

City

Paris

ZIP/Postal Code

75019

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Candice SABBEN, MD

First Name & Middle Initial & Last Name & Degree

Candice SABBEN, MD

Facility Name

Centre Hospitalier de Troyes

City

Troyes

ZIP/Postal Code

10003

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne AUBERTIN, MD

First Name & Middle Initial & Last Name & Degree

Anne AUBERTIN, MD

Facility Name

Centre Hospitalier de Verdun

City

Verdun

ZIP/Postal Code

55300

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sophie Marchal, MD

First Name & Middle Initial & Last Name & Degree

Sophie Marchal, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

34417212

Citation

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.

Results Reference

derived

Learn more about this trial

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

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