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Impact of Neutrophil Extracellular Traps on Tissue Plasminogen Activator Induced Thrombolysis in Acute Ischemic Stroke Patients (THROMBONETS)

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ClinicalTrials.gov Identifier: NCT02907736
Recruitment Status : Withdrawn (replaced by a new study)
First Posted : September 20, 2016
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:

Acute Ischemic stroke (AIS) remains a leading cause of adult disability, cognitive impairment and mortality worldwide despite the development of revascularization therapies (intravenous Tissue Plasminogen Activator (t-PA) and endovascular therapy). Thrombosis resistance after IV t-PA therapy is frequent especially in case of AIS with proximal occlusion. In recent years, neutrophil extracellular traps (NETs) have been identified as major triggers and structural factors of various forms of thrombosis. NETs are extracellular webs primarily composed of DNA from neutrophils. A recent study shows that the NETs burden in coronary thrombi is positively correlated with the infarct size and negatively correlated with electrocardiogram (ST-segment) resolution. This later study revealed that in vitro addition of DNase I accelerated the t-PA-induced thrombolysis of coronary thrombi. NETs could, in consequence, be promising targets for improved thrombolysis in AIS.

The aim of this study is to assess the impact of NETs composition of thrombi retrieved during endovascular therapy in AIS patients on IV t-PA induced thrombolysis, clinical outcome and AIS etiologies.


Condition or disease
Acute Stroke

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Actual Study Start Date : November 12, 2015
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : July 1, 2017



Primary Outcome Measures :
  1. thrombus origin [ Time Frame: baseline ]
    according to the etiology of the stroke (TOAST classification)

  2. red cells counts [ Time Frame: baseline ]
    quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining :

  3. white cells counts [ Time Frame: baseline ]
    quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining

  4. platlet counts [ Time Frame: baseline ]
    quantitative assessment of the relative fractions of the main constituents after Hematoxylin and Eosin staining



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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 stroke, admitted for endovascular therapy.
Criteria

Inclusion Criteria:

  • age > 18 years old
  • AIS secondary to a large vessel occlusion
  • admitted 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): NCT02907736


Locations
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France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Jean-Philippe Désilles, MD Fondation OPH A. de Rothschild
Study Chair: Mikael Mazighi, MD, PhD Fondation OPH A. de Rothschild

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02907736     History of Changes
Other Study ID Numbers: JDS_2015_45
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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Tissue Plasminogen Activator
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action