Risk Factors for Complications After Carotid Endarterectomy

Study Overview
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Brief Summary
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This study may determine the incidence of complications that occur after patients undergo a surgery called Carotid Endarterectomy (CEA), which is a surgery that aims to decrease the risk of strokes in patients with a condition called carotid stenosis. Medical records will be accessed to find any information pertaining to postoperative complications. Additionally, it may determine the cognitive dysfunction of patients undergoing CEA, assessed by Mini Mental Status Examination (MMSE).

Detailed Description
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This is a multicenter prospective observational study; data will be collected from two sites: the lead site in Columbus, Ohio, USA and an international site in Girona, Spain for a total of 354 patients. The objective of this study is to determine the incidence of complications that occur after patients undergo a surgery called Carotid Endarterectomy (CEA), which is a surgery that aims to decrease the risk of strokes in patients with a condition called carotid stenosis. Patients who undergo CEA are at increased risk of cardiovascular complications because of the high incidence of coexisting heart disease, high blood pressure, and diabetes. Common complications that occur after CEA are wound hematoma (collection of blood at the wound) and intracerebral hemorrhage (bleeding in the brain). Medical records will be accessed to find any information pertaining to postoperative complications. Another objective of this study is to determine the cognitive dysfunction of patients undergoing CEA. This will be measured by a Mini Mental Status Examination (MMSE) which will occur in person before the surgery and 30 days after the surgery over the phone. This study may provide data that will help identify how to optimize recovery for future CEA patients.

Official Title
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Risk Factors for Complications After Carotid Endarterectomy: A Multicenter International Observational Study

Conditions
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Postoperative Complications, Postoperative Cognitive Dysfunction

Intervention / Treatment
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* Procedure: Carotid endarterectomy
* Diagnostic Test: Mini Mental Status Examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients males or females, 18 years of age and older Scheduled to undergo Carotid Endarterectomy Exclusion Criteria: Pregnant women Incarcerated individuals Patients not able to consent for themselves Any disease or condition deemed by the investigator to disqualify the patient Participating in any interventional clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| carotid endarterectomy group<br>patients undergoing carotid endarterectomy | Procedure: Carotid endarterectomy<br>* Patients will undergo a surgery called carotid endarterectomy where a surgeon will remove material that causes carotid stenosis (i.e. plaque)<br>* Other names: CAE;Diagnostic Test: Mini Mental Status Examination<br>* Short questionnaire used to diagnose cognitive dysfunction<br>* Other names: MMSE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | Incidence of postoperative complications and identify the associated risk factors. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Dysfunction | the incidence of cognitive dysfunction based on Mini Mental Status Examination | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endarterectomy