Systemic Inflammation During Recanalization of Cerebral Arterial Occlusion

NCT04731584 | Completed

• 1 other identifier: 69HCL20_1080
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 4

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.

Conditions

Stroke; Systemic Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Control

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

Biological: Blood sample

Interventions

Blood sample BIOLOGICAL

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

AVC; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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" :
• 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
• NIHSS awareness score\> or = 2

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (4)

Service d'Anesthésie Réanimation Hôpital - Neurologique/Groupement Est

Bron, 69500, France

Location

Service de Neurologie vasculaire - Hôpital Neurologique/Groupement Est

Bron, 69500, France

Location

Service de Neuroradiologie interventionnelle - Hôpital Neurologique/Groupement Est

Bron, 69500, France

Location

Service d'Anesthésie Réanimation - Hôpital Edouard Herriot/Groupement Centre

Lyon, 69437, France

Location

MeSH Terms

Conditions

Stroke; Toxemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 1, 2021
• Study Start: April 7, 2021
• Primary Completion: June 12, 2021
• Study Completion: June 12, 2021
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)