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

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ClinicalTrials.gov Identifier: NCT02900833
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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.


Condition or disease
Acute Stroke

Study Type : Observational
Estimated Enrollment : 440 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Actual Study Start Date : March 24, 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019



Primary Outcome Measures :
  1. neutrophil counts [ Time Frame: before recanalization ]
    Plasma neutrophil activation bio-markers

  2. neutrophil counts [ Time Frame: immediately after recanalization ]
    Plasma neutrophil activation bio-markers

  3. neutrophil counts [ Time Frame: 24 hours after recanalization ]
    Plasma neutrophil activation bio-markers

  4. neutrophil protease counts [ Time Frame: before recanalization ]
  5. recanalization score [ Time Frame: immediately after endovascular procedure ]
    Thrombolysis in Cerebral Infarction classification (TICI)

  6. acute ischemic stroke etiology [ Time Frame: within 24 hours after endovascular procedure ]
    as defined by the Trial of Danaparoid (ORG10172) in Acute Stroke Treatment (TOAST classification)

  7. severity of neurologic symptoms [ Time Frame: baseline ]
    National Institutes of Health Stroke Scale (NIHSS)

  8. disruption of the blood-brain-barrier [ Time Frame: within 24 hours after endovascular procedure ]
    diagnosis on cerebral Computerized Tomography

  9. brain haemorrhage [ Time Frame: 24 hours after endovascular procedure ]
    National Institutes of Health Stroke Scale (NIHSS)

  10. Recovery of motor function after stroke [ Time Frame: 3 months ]
    modified Rankin scale

  11. mortality [ Time Frame: 3 months ]
  12. adhesion molecules counts [ Time Frame: before recanalization ]
  13. adhesion molecules counts [ Time Frame: immediately after recanalization ]
  14. adhesion molecules counts [ Time Frame: 24 hours after recanalization ]
  15. free plasma DNA counts [ Time Frame: before recanalization ]
  16. free plasma DNA counts [ Time Frame: immediately after recanalization ]
  17. free plasma DNA counts [ Time Frame: 24 hours after recanalization ]
  18. neutrophil protease counts [ Time Frame: immediately after recanalization ]
  19. neutrophil protease counts [ Time Frame: 24 hours after recanalization ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900833


Contacts
Contact: Laurence SALOMON, MD, PhD 0033148036431 lsalomon@for.paris

Locations
France
Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Laurence SALOMON, MD, PhD         
Sponsors and Collaborators
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

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02900833     History of Changes
Other Study ID Numbers: JDS_2015_46
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases