Impact of Neutrophil Activation in Acute Ischemic Stroke Patients Treated With Endovascular Therapy (NEUTROSTROKE)

Neutrophil Activation in Acute Ischemic Stroke Patients Treated With Endovascular Therapy

Clinical and experimental data suggest that neutrophil activation and extravasation are deleterious in acute ischemic stroke (AIS) involving an increased risk of unfavorable outcome and hemorrhagic transformation (HT). However, clinical trials targeting neutrophil recruitment in AIS patients were negative. Recently, an experimental study has shown that neutrophil activation and transmigration begin immediately after the occlusion. Inhibition of neutrophil recruitment several hours after the start of ischemia appears therefore too late to have a clinical relevance.

The objective is to study the time dependent impact of neutrophils in AIS and the predominant mediators in each time point to identify the appropriate therapeutic target and time window.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Stroke

• Study Type: Observational
• Enrollment (Estimated): 440

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Fondation Ophtalmologique Adolphe de Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute ischemic stroke secondary to a large vessel occlusion, undergoing endovascular therapy.

Description

Inclusion Criteria:

• age >= 18 years old
• acute ischemic stroke secondary to a large vessel occlusion.
• Patients hospitalized for endovascular therapy.

Exclusion Criteria:

• Pregnant or breast feeding patient
• patient under legal protection
• Patient opposition to participate in this study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality		3 months
neutrophil counts	Plasma neutrophil activation bio-markers	before recanalization
neutrophil counts	Plasma neutrophil activation bio-markers	immediately after recanalization
neutrophil counts	Plasma neutrophil activation bio-markers	24 hours after recanalization
neutrophil protease counts		before recanalization
recanalization score	Thrombolysis in Cerebral Infarction classification (TICI)	immediately after endovascular procedure
acute ischemic stroke etiology	as defined by the Trial of Danaparoid (ORG10172) in Acute Stroke Treatment (TOAST classification)	within 24 hours after endovascular procedure
severity of neurologic symptoms	National Institutes of Health Stroke Scale (NIHSS)	baseline
disruption of the blood-brain-barrier	diagnosis on cerebral Computerized Tomography	within 24 hours after endovascular procedure
brain haemorrhage	National Institutes of Health Stroke Scale (NIHSS)	24 hours after endovascular procedure
Recovery of motor function after stroke	modified Rankin scale	3 months
adhesion molecules counts		before recanalization
adhesion molecules counts		immediately after recanalization
adhesion molecules counts		24 hours after recanalization
free plasma DNA counts		before recanalization
free plasma DNA counts		immediately after recanalization
free plasma DNA counts		24 hours after recanalization
neutrophil protease counts		immediately after recanalization
neutrophil protease counts		24 hours after recanalization

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Jean-Philippe DESILLES, MD, Fondation OPH A de Rothschild; Study Chair: Mikael MAZIGHI, MD, PhD, Fondation OPH A de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2016
• Primary Completion (Actual): December 12, 2022
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: September 9, 2016
• First Posted (Estimated): September 14, 2016

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: JDS_2015_46