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

Stroke, Acute Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03364296
• Other study ID #: PHRCI 2016/FLAG1 - RICHARD /MS
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: March 1, 2025

Study information

• Verified date: June 2022
• Source: Central Hospital, Nancy, France
• Contact: Sébastien RICHARD, MD
• Phone: 0033383852256
• Email: s.richard[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 930
• Est. completion date: March 1, 2025
• Est. primary completion date: September 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Ischemia
• Stroke
• Stroke, Acute

Intervention

Other:
• Blood Samples
Blood sample retrieved for biological assessment and biobanking

Locations

Country	Name	City	State
France	Centre Hospitalier de Bar-Le-Duc	Bar-le-Duc
France	Hôpital Central	Nancy
France	Fondation Adolphe de Rothschild	Paris
France	Centre Hospitalier de Troyes	Troyes
France	Centre Hospitalier de Verdun	Verdun

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (<4.5 hours) between cerebral infarction onset and blood sample for determination for GST-p level	ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-p 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-p plasmatic level to identify cerebral infarction of less than 4.5 hours.
Primary	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	Time (<3 and 6 hours) between cerebral infarction onset and blood sample for determination for GST-p and PRDX1 levels	ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-p and PRDX1 plasmatic levels to identify cerebral infarction of less than 3 and 6 hours.	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-p and PRDX1 plasmatic levels to identify cerebral infarction of less than 3 hours, and < 6 hours
Secondary	Blood sample for determination for GST-p 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-p and PRDX1 plasmatic levels to identify and quantify ischemic penumbra.	The patient will be included within the 12 hours following stroke onset with one blood sample (defining GST-p and PRDX1 plasmatic levels), and cerebral MRI (defining Diffusion/Perfusion mismatch or penumbra) within the 30 minutes following blood sample.
Secondary	Blood sample for determination for GST-p 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-p and PRDX1 plasmatic levels to identify stroke.	The patient will be included within the 12 hours following neurological deficiency onset with one blood sample (defining GST-p and PRDX1 plasmatic levels), and cerebral MRI (defining stroke) within the 30 minutes following blood sample.
Secondary	Blood sample for determination for GST-p 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-p and PRDX1 plasmatic levels to identify cerebral infarction.	The patient will be included within the 12 hours following neurological deficiency onset with one blood sample (defining GST-p and PRDX1 plasmatic levels), and cerebral MRI (defining stroke) within the 30 minutes following blood sample.
Secondary	Blood sample for determination for GST-p 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-p and PRDX1 plasmatic levels to identify hemorrhagic stroke.	The patient will be included within the 12 hours following neurological deficiency onset with one blood sample (defining GST-p and PRDX1 plasmatic levels), and cerebral MRI (defining stroke) within the 30 minutes following blood sample.
Secondary	MRI Diffusion/FLAIR mismatch (yes versus no)		The patient will be included within the 12 hours following stroke onset with one blood sample (defining GST-p and PRDX1 plasmatic levels), and cerebral MRI (defining Diffusion/Perfusion mismatch or penumbra) within the 30 minutes following blood sample.
Secondary	Volume of cerebral infarction assessed by MRI diffusion weighted imaging.		The patient will be included within the 12 hours following stroke onset with one blood sample (defining GST-p and PRDX1 plasmatic levels), and cerebral MRI (defining Diffusion/Perfusion mismatch or penumbra) within the 30 minutes following blood sample.