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

NCT05004233 | Recruiting

• 2 other identifiers: 20CH0262021-A00292-39
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

Ischemic stroke; Ultrastructural characterization; Transmission electron microscopy; platelet dysfunction; Blood Coagulation Disorder

Outcome Measures

Primary Outcomes (5)

• 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

  Day 5

• 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

  Day 5

• 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

  Day 5

• 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

  Day 5

• 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

  Day 5

Secondary Outcomes (1)

• The incidence of a composite endpoint

  Month 6

Study Arms (1)

Ischemic stroke patients

EXPERIMENTAL

Patients hospitalized for an ischemic stroke.

Biological: Blood collection before antiplatelet treatment; Biological: Blood collection after antiplatelet treatment

Interventions

Blood collection before antiplatelet treatment BIOLOGICAL

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

Ischemic stroke patients

Blood collection after antiplatelet treatment BIOLOGICAL

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

Ischemic stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindications regarding antiplatelet agent(s) and/or at least one excipient according to Summary of Product Characteristics (SPC).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Centre Hospitalier Universitaire de St-Etienne

Saint-Etienne, 42055, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 35379612 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• PIERRE GARNIER, MD

  CHU DE SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PIERRE GARNIER, MD

CONTACT

(0)477127805; pierre.garnier@chu-st-etienne.fr

Nora MALLOUK, PhD

CONTACT

(0)4.77.42.14.34; nora.mallouk@univ-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 13, 2021
• Study Start: December 13, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)