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

Acute Stroke Clinical Trial

— NEUTROSTROKE  

Official title:

Neutrophil Activation in Acute Ischemic Stroke Patients Treated With Endovascular Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02900833
• Other study ID #: JDS_2015_46
• Status: Active, not recruiting
• Start date: March 24, 2016
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 440
• Est. completion date: August 31, 2024
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

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