ELECTROSTROKE: Transmission Electron Microscopy Images for Platelet Ultrastructural Criteria Before and After the Onset of an Antiplatelet Agent

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05004233
Collaborator
(none)
50
1
1
17
2.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Blood collection before antiplatelet treatment
  • Biological: Blood collection after antiplatelet treatment
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Transmission Electron Microscopy Images for Platelet Ultrastructural Criteria Before and After the Onset of an Antiplatelet Agent
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ischemic stroke patients

Patients hospitalized for an ischemic stroke.

Biological: Blood collection before antiplatelet treatment
Blood sample (17ml) will be collected in the neurovascular department to be processed for platelet ultrastructural analysis before the onset of an antiplatelet treatment

Biological: Blood collection after antiplatelet treatment
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

Outcome Measures

Primary Outcome Measures

  1. Morphology of the platelet : [Day 5]

    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

  2. Type of granules in the platelet [Day 5]

    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

  3. Distribution of mitochondria, glycogen and dense tubular system in platelets [Day 5]

    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

  4. Structure of open canalicular system in platelets [Day 5]

    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

  5. Number of patients with a microtubular ring on the equatorial section plane (peripheral or centralized) in platelets [Day 5]

    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

  1. The incidence of a composite endpoint [Month 6]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Universitaire de St-Etienne Saint-Étienne France 42055

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: PIERRE GARNIER, MD, CHU DE SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT05004233
Other Study ID Numbers:
  • 20CH026
  • 2021-A00292-39
First Posted:
Aug 13, 2021
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2021