Systemic Inflammation During Recanalization of Cerebral Arterial Occlusion

Stroke Clinical Trial

— CONVASC-I  

Official title:

Systemic Inflammation During Recanalization of Cerebral Arterial Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04731584
• Other study ID #: 69HCL20_1080
• Status: Completed
• Start date: April 7, 2021
• Est. completion date: June 12, 2021

Study information

• Verified date: February 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 12, 2021
• Est. primary completion date: June 12, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Sepsis
• Stroke
• Systemic Infection

Intervention

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

Locations

Country	Name	City	State
France	Service d'Anesthésie Réanimation Hôpital - Neurologique/Groupement Est	Bron
France	Service de Neurologie vasculaire - Hôpital Neurologique/Groupement Est	Bron
France	Service de Neuroradiologie interventionnelle - Hôpital Neurologique/Groupement Est	Bron
France	Service d'Anesthésie Réanimation - Hôpital Edouard Herriot/Groupement Centre	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation parameters description	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	1 day