Carotid Artery Diseases, Stroke, Acute
Conditions
Keywords
Carotid thromboendarterectomy, Thromboembolic Stroke, Platelet function, Aggregometry, Vascular surgery, mortality, neurological events
Brief summary
Several studies have shown an association between platelet function and stroke in patients undergoing carotid thromboendarterectomy (TEA). The present study will assess the correlation between platelet function evaluated by the impedance aggregometry and neurological events in patients undergoing carotid TEA.
Detailed description
Carotid thrombendarterectomy (TEA) is effective in preventing strokes which are a major cause of mortality and morbidity. Nevertheless, almost 10% of patients undergoing TEA develop a transient and/or permanent neurological injury. There is a growing body of evidence that platelet function is associated with perioperative neurological events in this setting, although the vast majority of patients undergoing carotid TEA are already on antiplatelet agents. The aim of the present study will be to assess the correlation between the platelet function evaluated by the impedance aggregometry (Multiplate ® Analyzer, Roche, Basel, Switzerland) and neurological events in patients undergoing carotid TEA.
Interventions
DIAGNOSTIC_TESTPlatelet Aggregometry Testing
1.6 ml of blood collected in hirudin-coated tubes before the surgery
Sponsors
Scientific Institute San Raffaele
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Carotid Artery Diseases undergoing carotid thrombendarterectomy * Signed consent
Exclusion criteria
* Atrial fibrillation * New oral anticoagulant * Oral Vitamin k inhibitors * Platelet count \<80000 per microliter * Ongoing ischemic stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet function and neurological events | immediately before the surgery | The platelet function will be evaluated by Multiple Electrode Aggregometry (Multiplate). It will be asses the correlation between thrombin receptor activator peptide 6 (TRAP test), adenosine-5'-diphosphate (ADP test) and arachidonic acid (ASPI test) expressed in arbitrary units area under the curve and neurological events in patients undergoing carotid thrombendarterectomy |
| TRAP, ADP and ASPI thresholds to predict neurological events | immediately before the surgery | It will be find the best cut-off for TRAP, ADP and, ASPI in predicting neurological events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of thromboembolic neurological events | within 1 month of patients' enrolled or before the hospital discharge | — |
| Occurrence of any complications | within 1 month of patients' enrolled or before the hospital discharge | Occurrence of surgical and medical complications |
| 6 months and 1 year mortality | 6 months and 1 year | Mortality at 6 months and 1 years after carotid surgery |
| 6 months and 1 year neurological events | 6 months and 1 year | Occurrence of neurological events after 6 months and 1 year after the procedure |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORFabrizio Monaco, MD
San Raffaele Scientific Institute
Outcome results
None listed