CONVASC-I: Systemic Inflammation During Recanalization of Cerebral Arterial Occlusion

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04731584
Collaborator
(none)
30
4
7
7.5
1.1

Study Details

Study Description

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 Phase
  • Biological: Blood sample

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Systemic Inflammation During Recanalization of Cerebral Arterial Occlusion
Anticipated Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. Inflammation parameters description [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 Service d'Anesthésie Réanimation Hôpital - Neurologique/Groupement Est Bron France 69500
2 Service de Neurologie vasculaire - Hôpital Neurologique/Groupement Est Bron France 69500
3 Service de Neuroradiologie interventionnelle - Hôpital Neurologique/Groupement Est Bron France 69500
4 Service d'Anesthésie Réanimation - Hôpital Edouard Herriot/Groupement Centre Lyon France 69437

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT04731584
Other Study ID Numbers:
  • 69HCL20_1080
First Posted:
Feb 1, 2021
Last Update Posted:
Feb 1, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2021