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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Aggregometry Testing | Diagnostic Test | 1.6 ml of blood collected in hirudin-coated tubes before the surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Platelet function and neurological events | 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 | immediately before the surgery |
| TRAP, ADP and ASPI thresholds to predict neurological events | It will be find the best cut-off for TRAP, ADP and, ASPI in predicting neurological events | immediately before the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of thromboembolic neurological events | within 1 month of patients' enrolled or before the hospital discharge | |
| Occurrence of any complications | Occurrence of surgical and medical complications |
| Measure | Description | Time Frame |
|---|---|---|
| Assesment of the health state at 6 months and 1 year after surgery | The health state will be evaluated by EuroQol 5-dimensions 3 level test at 6 months and 1 year | 6 months and 1 year |
Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing carotid thromboendoarterectomy
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| Name | Affiliation | Role |
|---|---|---|
| Fabrizio Monaco, MD | San Raffaele Scientific Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientific Institute San Raffaele | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32856558 | Background | Ball STE, Taylor R, McCollum CN. Resistance to Antiplatelet Therapy Is Associated With Symptoms of Cerebral Ischemia in Carotid Artery Disease. Vasc Endovascular Surg. 2020 Nov;54(8):712-717. doi: 10.1177/1538574420947235. Epub 2020 Aug 28. | |
| 19287328 | Background | Reavey-Cantwell JF, Fox WC, Reichwage BD, Fautheree GL, Velat GJ, Whiting JH, Chi YY, Hoh BL. Factors associated with aspirin resistance in patients premedicated with aspirin and clopidogrel for endovascular neurosurgery. Neurosurgery. 2009 May;64(5):890-5; discussion 895-6. doi: 10.1227/01.NEU.0000341904.39691.2F. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002340 | Carotid Artery Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| within 1 month of patients' enrolled or before the hospital discharge |
| 6 months and 1 year mortality | Mortality at 6 months and 1 years after carotid surgery | 6 months and 1 year |
| 6 months and 1 year neurological events | Occurrence of neurological events after 6 months and 1 year after the procedure | 6 months and 1 year |
| 21557809 | Background | Sacco S, Stracci F, Cerone D, Ricci S, Carolei A. Epidemiology of stroke in Italy. Int J Stroke. 2011 Jun;6(3):219-27. doi: 10.1111/j.1747-4949.2011.00594.x. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |