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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00292-39 | Other Identifier | ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ischemic stroke patients | Experimental | Patients hospitalized for an ischemic stroke. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 :
| 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 :
| 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
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications regarding antiplatelet agent(s) and/or at least one excipient according to Summary of Product Characteristics (SPC).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PIERRE GARNIER, MD | Contact | (0)477127805 | +33 | pierre.garnier@chu-st-etienne.fr |
| Nora MALLOUK, PhD | Contact | (0)4.77.42.14.34 | +33 | nora.mallouk@univ-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| PIERRE GARNIER, MD | CHU DE SAINT-ETIENNE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de St-Etienne | Recruiting | Saint-Etienne | 42055 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35379612 | Derived | 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. |
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| 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 |
|
| Day 5 |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D001778 | Blood Coagulation Disorders |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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