Clinical trial NCT02900833: Impact of Neutrophil Activation in Acute Ischemic Stroke Patients Treated With Endovascular Therapy
Official title: Neutrophil Activation in Acute Ischemic Stroke Patients Treated With Endovascular Therapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Stroke
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-14
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute ischemic stroke secondary to a large vessel occlusion, undergoing endovascular therapy.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: neutrophil counts
timeFrame: before recanalization
measure: neutrophil counts
timeFrame: immediately after recanalization
measure: neutrophil counts
timeFrame: 24 hours after recanalization
measure: neutrophil protease counts
timeFrame: before recanalization
measure: recanalization score
timeFrame: immediately after endovascular procedure
measure: acute ischemic stroke etiology
timeFrame: within 24 hours after endovascular procedure
measure: severity of neurologic symptoms
timeFrame: baseline
measure: disruption of the blood-brain-barrier
timeFrame: within 24 hours after endovascular procedure
measure: brain haemorrhage
timeFrame: 24 hours after endovascular procedure
measure: Recovery of motor function after stroke
timeFrame: 3 months
measure: mortality
timeFrame: 3 months
measure: adhesion molecules counts
timeFrame: before recanalization
measure: adhesion molecules counts
timeFrame: immediately after recanalization
measure: adhesion molecules counts
timeFrame: 24 hours after recanalization
measure: free plasma DNA counts
timeFrame: before recanalization
measure: free plasma DNA counts
timeFrame: immediately after recanalization
measure: free plasma DNA counts
timeFrame: 24 hours after recanalization
measure: neutrophil protease counts
timeFrame: immediately after recanalization
measure: neutrophil protease counts
timeFrame: 24 hours after recanalization
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Jean-Philippe DESILLES, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondation OPH A de Rothschild
name: Mikael MAZIGHI, MD, PhD
role: STUDY_CHAIR
References: