Clinical trial NCT03364296: Biological Dating of Cerebral Ischemia With GST-π/PRDX1 to Detect Patients With Stroke of Unknown Onset Within the Therapeutic Window of Thrombolysis
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
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Acute
Keywords: Acute stroke, Biomarkers
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 930
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Time (<4.5 hours) between cerebral infarction onset and blood sample for determination for GST-π level
timeFrame: 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.
measure: Time (<4.5 hours) between cerebral infarction onset and blood sample for determination for PRDX1 levels
timeFrame: 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:
measure: Time (<3 and 6 hours) between cerebral infarction onset and blood sample for determination for GST-π and PRDX1 levels
timeFrame: 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
measure: Blood sample for determination for GST-π and PRDX1 levels Cerebral MRI for Diffusion/Perfusion mismatch defining ischemic penumbra
timeFrame: 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.
measure: Blood sample for determination for GST-π and PRDX1 levels Cerebral MRI for diagnosis of stroke vs. other diagnosis
timeFrame: 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.
measure: Blood sample for determination for GST-π and PRDX1 levels Cerebral MRI for diagnosis of ischemic stroke vs. other diagnosis
timeFrame: 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.
measure: Blood sample for determination for GST-π and PRDX1 levels Cerebral MRI for diagnosis of hemorrhagic stroke vs. other diagnosis
timeFrame: 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.
measure: MRI Diffusion/FLAIR mismatch (yes versus no)
timeFrame: 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.
measure: Volume of cerebral infarction assessed by MRI diffusion weighted imaging.
timeFrame: 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.
Other outcomes:
Locations:
city: Bar-le-Duc
country: France
facility: Centre Hospitalier de Bar-Le-Duc
city: Nancy
country: France
facility: Hôpital Central
city: Paris
country: France
facility: Fondation Adolphe de Rothschild
city: Troyes
country: France
facility: Centre Hospitalier de Troyes
city: Verdun
country: France
facility: Centre Hospitalier de Verdun
Study officials:
References:
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.