Ischemic Stroke
Conditions
Keywords
Ischemic stroke, Ultrastructural characterization, Transmission electron microscopy, platelet dysfunction, Blood Coagulation Disorder
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.
Interventions
BIOLOGICALBlood 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
BIOLOGICALBlood 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
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
France
Contacts
Primary ContactPIERRE GARNIER, MD
Backup ContactNora MALLOUK, PhD
Outcome results
None listed