Transmission Electron Microscopy Images for Platelet Ultrastructural Criteria Before and After the Onset of an Antiplatelet Agent (ELECTROSTROKE)
Primary Purpose
Ischemic Stroke
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood collection before antiplatelet treatment
Blood collection after antiplatelet treatment
Sponsored by
About this trial
This is an interventional prevention trial for Ischemic Stroke focused on measuring Ischemic stroke, Ultrastructural characterization, Transmission electron microscopy, platelet dysfunction, Blood Coagulation Disorder
Eligibility Criteria
Inclusion Criteria:
- Social security affiliation
- Signed informed consent
- patients hospitalized for an non cardioembolic ischemic stroke requiring the onset of an antiplatelet therapy according to the usual guidelines recommendations
Exclusion Criteria:
Contraindications regarding antiplatelet agent(s) and/or at least one excipient according to Summary of Product Characteristics (SPC).
Sites / Locations
- Centre Hospitalier Universitaire de St-Etienne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ischemic stroke patients
Arm Description
Patients hospitalized for an ischemic stroke.
Outcomes
Primary Outcome Measures
Morphology of the platelet :
Platelet ultrastructural criteria will be obtained from transmission electron microscopy images of platelet ultrathin sections before and after (5 days) initiation of antiaggregant therapy in patients with noncardioembolic ICA
the morphology of the platelet :
discoid or round
with the emission of filipodia, pseudopodia and lamellipodia
Type of granules in the platelet
Platelet ultrastructural criteria will be obtained from transmission electron microscopy images of platelet ultrathin sections before and after (5 days) initiation of antiaggregant therapy in patients with noncardioembolic ICA
- the observation of granules :
alpha granules
dense granules
Distribution of mitochondria, glycogen and dense tubular system in platelets
Platelet ultrastructural criteria will be obtained from transmission electron microscopy images of platelet ultrathin sections before and after (5 days) initiation of antiaggregant therapy in patients with noncardioembolic ICA
Structure of open canalicular system in platelets
Platelet ultrastructural criteria will be obtained from transmission electron microscopy images of platelet ultrathin sections before and after (5 days) initiation of antiaggregant therapy in patients with noncardioembolic ICA
- the open canalicular system
dilated or not
associated with degranulation or not
Number of patients with a microtubular ring on the equatorial section plane (peripheral or centralized) in platelets
Platelet ultrastructural criteria will be obtained from transmission electron microscopy images of platelet ultrathin sections before and after (5 days) initiation of antiaggregant therapy in patients with noncardioembolic ICA
Secondary Outcome Measures
The incidence of a composite endpoint
The incidence of a composite of cardiovascular events (radiologically documented recurrent ischemic stroke, transient ischemic attacks, coronary artery disease (acute coronary syndromes, myocardial infarction), obliterating arterial disease of the lower limb, death of cardiovascular origin)
Full Information
NCT ID
NCT05004233
First Posted
July 16, 2021
Last Updated
April 14, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT05004233
Brief Title
Transmission Electron Microscopy Images for Platelet Ultrastructural Criteria Before and After the Onset of an Antiplatelet Agent
Acronym
ELECTROSTROKE
Official Title
Transmission Electron Microscopy Images for Platelet Ultrastructural Criteria Before and After the Onset of an Antiplatelet Agent
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the pilot study is to collect all the ultrastructural platelet characteristics by transmission electron microscopy before and after the onset of an antiplatelet treatment in patients hospitalized for an ischemic stroke ; and to assess recurrence of Ischemic Cerebral Accident (ICA) at 6 months in patients hospitalized for Ischemic stroke.
Detailed Description
Ischaemic stroke is the leading cause of adult disability. Thus, a strategy based on an efficient antiplatelet therapy has been developed to prevent platelet activation occurring in the acute phase of non-cardioembolic ischemic stroke.
The biological monitoring of the antiplatelet therapy with available platelet function assays do not provide a global integrative approach considering all the mechanisms involved in platelet activation.
Platelet transmission electron microscopy recently validated for assessing distinct ultrastructural abnormalities is a reliable morphological platelet structural analysis tool.
Ultrastructural criteria could be identified and be useful for the assessment of the degree of platelet activation and thus the biological efficiency of antiplatelet agents. All the activation transduction signals are integrated and all antiplatelet agents can be assessed.
The aim of the pilot study is to collect all the ultrastructural platelet characteristics by transmission electron microscopy before and after the onset of an antiplatelet treatment in patients hospitalized for an ischemic stroke.
Investigators expect to identify ultrastructural characteristics that will be correlated with the platelet degree of activation to guide clinicians in decision-making regarding the antiplatelet therapy strategy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Ischemic stroke, Ultrastructural characterization, Transmission electron microscopy, platelet dysfunction, Blood Coagulation Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ischemic stroke patients
Arm Type
Experimental
Arm Description
Patients hospitalized for an ischemic stroke.
Intervention Type
Biological
Intervention Name(s)
Blood collection before antiplatelet treatment
Intervention Description
Blood sample (17ml) will be collected in the neurovascular department to be processed for platelet ultrastructural analysis before the onset of an antiplatelet treatment
Intervention Type
Biological
Intervention Name(s)
Blood collection after antiplatelet treatment
Intervention Description
A follow-up will be carried out 5 to 8 days after the initiation of the treatment.
A blood test will be taken in the NeuroVascular Unit
Primary Outcome Measure Information:
Title
Morphology of the platelet :
Description
Platelet ultrastructural criteria will be obtained from transmission electron microscopy images of platelet ultrathin sections before and after (5 days) initiation of antiaggregant therapy in patients with noncardioembolic ICA
the morphology of the platelet :
discoid or round
with the emission of filipodia, pseudopodia and lamellipodia
Time Frame
Day 5
Title
Type of granules in the platelet
Description
Platelet ultrastructural criteria will be obtained from transmission electron microscopy images of platelet ultrathin sections before and after (5 days) initiation of antiaggregant therapy in patients with noncardioembolic ICA
- the observation of granules :
alpha granules
dense granules
Time Frame
Day 5
Title
Distribution of mitochondria, glycogen and dense tubular system in platelets
Description
Platelet ultrastructural criteria will be obtained from transmission electron microscopy images of platelet ultrathin sections before and after (5 days) initiation of antiaggregant therapy in patients with noncardioembolic ICA
Time Frame
Day 5
Title
Structure of open canalicular system in platelets
Description
Platelet ultrastructural criteria will be obtained from transmission electron microscopy images of platelet ultrathin sections before and after (5 days) initiation of antiaggregant therapy in patients with noncardioembolic ICA
- the open canalicular system
dilated or not
associated with degranulation or not
Time Frame
Day 5
Title
Number of patients with a microtubular ring on the equatorial section plane (peripheral or centralized) in platelets
Description
Platelet ultrastructural criteria will be obtained from transmission electron microscopy images of platelet ultrathin sections before and after (5 days) initiation of antiaggregant therapy in patients with noncardioembolic ICA
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
The incidence of a composite endpoint
Description
The incidence of a composite of cardiovascular events (radiologically documented recurrent ischemic stroke, transient ischemic attacks, coronary artery disease (acute coronary syndromes, myocardial infarction), obliterating arterial disease of the lower limb, death of cardiovascular origin)
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Social security affiliation
Signed informed consent
patients hospitalized for an non cardioembolic ischemic stroke requiring the onset of an antiplatelet therapy according to the usual guidelines recommendations
Exclusion Criteria:
Contraindications regarding antiplatelet agent(s) and/or at least one excipient according to Summary of Product Characteristics (SPC).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PIERRE GARNIER, MD
Phone
(0)477127805
Ext
+33
Email
pierre.garnier@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nora MALLOUK, PhD
Phone
(0)4.77.42.14.34
Ext
+33
Email
nora.mallouk@univ-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PIERRE GARNIER, MD
Organizational Affiliation
CHU DE SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de St-Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre GARNIER, MD
First Name & Middle Initial & Last Name & Degree
Magali EPINAT, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35379612
Citation
Mallouk N, Garcin A, Li G, Epinat M, Szczepaniak C, Hien OF, Mismetti P, Garnier P. Platelet transmission electron microscopy for the assessment of poor biological response to antiplatelet agent: pilot descriptive and prospective study - ELECTROSTROKE. BMJ Open. 2022 Apr 4;12(4):e050060. doi: 10.1136/bmjopen-2021-050060.
Results Reference
derived
Learn more about this trial
Transmission Electron Microscopy Images for Platelet Ultrastructural Criteria Before and After the Onset of an Antiplatelet Agent
We'll reach out to this number within 24 hrs