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Systemic Inflammation During Recanalization of Cerebral Arterial Occlusion (CONVASC-I)

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ClinicalTrials.gov Identifier: NCT04731584
Recruitment Status : Not yet recruiting
First Posted : February 1, 2021
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:
Strokes management, secondary to proximal arterial occlusion, by endovascular thrombectomy (TM) is now well established. The immuno-inflammatory events of reperfusion after TM are discussed. Systemic inflammation is a major factor suggested to explain the limited recovery of the ischemic parenchyma. Understanding these phenomena is necessary before developing an immunomodulatory strategy.

Condition or disease Intervention/treatment
Stroke Systemic Infection Biological: Blood sample

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Systemic Inflammation During Recanalization of Cerebral Arterial Occlusion
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
AVC
Patients hospitalized for TM after a proximal ischemic stroke of the middle cerebral artery and whose reperfusion is satisfactory (TICI 2b, 2c and 3). Additional blood sample will be taken during usual treatment the day of the stroke.
 Biological: Blood sample
Patients from 2 groups will undergo blood sample (during a blood sample for there care) and inflammation parameters will be measure the day of the stroke
Control
Population of control patients, consisting of patients admitted on an outpatient basis for a diagnostic cerebral arteriography.
 Biological: Blood sample
Patients from 2 groups will undergo blood sample (during a blood sample for there care) and inflammation parameters will be measure the day of the stroke


Outcome Measures
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Primary Outcome Measures :
  1. Inflammation parameters description [ Time Frame: 1 day ]
    Inflammatory parameters such as CRP, IL-6, IL-10, HLA-DR, TNF-alpha, polymorphonuclear chemotaxis, CD-4, T-lymphocytes will be measure in blood sample


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

Patients hospitalized for TM after a proximal ischemic stroke of the middle cerebral artery and whose reperfusion is satisfactory (TICI 2b, 2c and 3).

Population of control patients, consisting of patients admitted on an outpatient basis for diagnostic cerebral arteriography.

Criteria

GROUP "AVC" :

Inclusion Criteria:

  • Adults patient (s)
  • Ischemic stroke by occlusion of a middle cerebral artery (proximal portion M1)
  • Initial diagnostic MRI infusion
  • TM with complete reperfusion (TICI 2b, 2c or 3)
  • TM performed under local anesthesia +/- anxiolysis, or sedation including propofol
  • mRS prior to stroke <2
  • Barthel index <90
  • Included in the HIBISCUS cohort
  • Patient who was informed and did not object to participating in the study OR included through the emergency procedure then collection of his non-objection or that of his trusted person as soon as possible

Exclusion Criteria:

  • NIHSS awareness score> or = 2
  • Haemorrhagic complication before thrombectomy
  • Pregnant woman
  • Multiple vascular occlusions
  • Occlusions of posterior or anterior cerebral territories other than M1
  • Protected major
  • TM performed under general anesthesia
  • Other vital failure than neurological failure

GROUP "CONTROL" :

Inclusion Criteria:

  • Adults patient (s)
  • mRS <2
  • Barthel index <90
  • Requiring diagnostic arteriography for routine check-up of a cerebrovascular malformation
  • Patient who was informed and did not object to participating in the study

Exclusion Criteria:

  • NIHSS awareness score> or = 2
  • Pregnant woman
  • Protected major
  • Exam performed under general anesthesia
Contacts and Locations
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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): NCT04731584


Contacts
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Contact: Baptiste BOUCHIER, Dr 04 72 35 75 76 ext +33 baptiste.bouchier@chu-lyon.fr
Contact: Julien BERTHILLER 04 27 85 63 01 ext +33 julien.berthiller@chu-lyon.fr

Locations
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France
Service d'Anesthésie Réanimation Hôpital - Neurologique/Groupement Est
Bron, France, 69500
Contact: Baptiste BOUCHIER, Dr    04 72 35 75 76 ext +33    baptiste.bouchier@chu-lyon.fr   
Sub-Investigator: Florian CONTARD         
Service de Neurologie vasculaire - Hôpital Neurologique/Groupement Est
Bron, France, 69500
Contact: Laura MECHTOUFF, Dr    04 72 35 78 07 ext +33    laura.mechtouff@chu-lyon.fr   
Service de Neuroradiologie interventionnelle - Hôpital Neurologique/Groupement Est
Bron, France, 69500
Contact: Omer EKER, Pr    04 72 11 93 73 ext +33    omer.eker@chu-lyon.fr   
Service d'Anesthésie Réanimation - Hôpital Edouard Herriot/Groupement Centre
Lyon, France, 69437
Contact: Anne-Claire LUKASZEWICZ, Pr    04 72 11 13 27 ext +33    anne-claire.lukaszewicz@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04731584    
Other Study ID Numbers: 69HCL20_1080
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Inflammation
Pathologic Processes
Infections
Systemic Inflammatory Response Syndrome