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Trial record 66 of 581 for:    reduced glutathione

Biological Dating of Cerebral Ischemia With GST-π/PRDX1 to Detect Patients With Stroke of Unknown Onset Within the Therapeutic Window of Thrombolysis (FLAG1)

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ClinicalTrials.gov Identifier: NCT03364296
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.

Condition or disease Intervention/treatment Phase
Stroke, Acute Other: Blood Samples Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 945 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : July 13, 2021
Estimated Study Completion Date : January 1, 2022

Arm Intervention/treatment
Patients hospitalized for stroke Other: Blood Samples
Blood sample retrieved for biological assessment and biobanking




Primary Outcome Measures :
  1. Time (<4.5 hours) between cerebral infarction onset and blood sample for determination for GST-π level [ 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. ]
    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.

  2. Time (<4.5 hours) between cerebral infarction onset and blood sample for determination for PRDX1 levels [ 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 ]
    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 :
  1. Time (<3 and 6 hours) between cerebral infarction onset and blood sample for determination for GST-π and PRDX1 levels [ 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 ]
    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.

  2. Time (<3, 4.5 and 6 hours) between cerebral infarction onset and blood sample for determination for GST-π and PRDX1 levels Time (<3, 4.5 and 6 hours) between cerebral infarction onset and cerebral MRI defining Diffusion/FLAIR [ Time Frame: Patients will be dichotomized with blood sample and MRI performed <3 and >3, <4.5 and >4.5, and <6 and >6 hours after stroke onset to determine diagnostic performance of GST-π/PRDX1 levels and MRI to identify cerebral infarction <3, 4.5 and 6 hours ]
    ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π and PRDX1 plasmatic levels and Diffusion/FLAIR mismatch to identify cerebral infarction of less than 3, 4.5 and 6 hours.

  3. Blood sample for determination for GST-π and PRDX1 levels Cerebral MRI for Diffusion/Perfusion mismatch defining 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. ]
    ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π and PRDX1 plasmatic levels to identify and quantify ischemic penumbra.

  4. Blood sample for determination for GST-π and PRDX1 levels Cerebral MRI for diagnosis of stroke vs. other diagnosis [ 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. ]
    ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π and PRDX1 plasmatic levels to identify stroke.

  5. Blood sample for determination for GST-π and PRDX1 levels Cerebral MRI for diagnosis of ischemic stroke vs. other diagnosis [ 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. ]
    ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π and PRDX1 plasmatic levels to identify cerebral infarction.

  6. Blood sample for determination for GST-π and PRDX1 levels Cerebral MRI for diagnosis of hemorrhagic stroke vs. other diagnosis [ 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. ]
    ROC analysis will be performed to determine diagnostic performance (sensitivity, specificity) of GST-π and PRDX1 plasmatic levels to identify hemorrhagic stroke.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Known and precise time of stroke onset
  • Stroke onset <12 hours
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364296


Contacts
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Contact: Sébastien RICHARD, MD 0033383852256 s.richard@chru-nancy.fr
Contact: Sanae BOUALI, PhD s.bouali@chru-nancy.fr

Locations
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France
Centre Hospitalier de Bar-Le-Duc Recruiting
Bar-le-Duc, France, 55000
Contact: Karine LAVANDIER, MD         
Hôpital de Mercy Not yet recruiting
Metz, France, 57245
Contact: Xavier DUCROCQ, Professor         
Hôpital Central Recruiting
Nancy, France, 54000
Contact: Sébastien RICHARD, Professor       s.richard@chru-nancy.fr   
Fondation Adolphe de Rothschild Not yet recruiting
Paris, France, 75019
Contact: Candice SABBEN, MD         
Centre Hospitalier de Troyes Recruiting
Troyes, France, 10003
Contact: Anne AUBERTIN, MD         
Centre Hospitalier de Verdun Not yet recruiting
Verdun, France, 55300
Contact: Sophie Marchal, MD         
Sponsors and Collaborators
Central Hospital, Nancy, France

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03364296     History of Changes
Other Study ID Numbers: PHRCI 2016/FLAG1 - RICHARD /MS
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Central Hospital, Nancy, France:
Acute stroke, Biomarkers

Additional relevant MeSH terms:
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Stroke
Ischemia
Brain Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction