Risk Factors for Complications After Carotid Endarterectomy

Terminated

• Conditions: Postoperative Cognitive Dysfunction; Postoperative Complications
• Interventions: Procedure: Carotid endarterectomy; Diagnostic Test: Mini Mental Status Examination

• Registration Number: NCT03788980
• Lead Sponsor: Ohio State University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-04-13
• Study First Submitted: 2018-12-26
• Study First Submitted QC: 2018-12-26
• Study First Posted: 2018-12-28
• Primary Completion: 2019-07-09
• Study Completion: 2019-07-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients males or females, 18 years of age and older
• Scheduled to undergo Carotid Endarterectomy

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Exclusion Criteria

1. Pregnant women
2. Incarcerated individuals
3. Patients not able to consent for themselves
4. Any disease or condition deemed by the investigator to disqualify the patient
5. Participating in any interventional clinical trial

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
carotid endarterectomy group	Mini Mental Status Examination	patients undergoing carotid endarterectomy
carotid endarterectomy group	Carotid endarterectomy	patients undergoing carotid endarterectomy

Primary Outcome Measures

Name	Time	Method
Complication rate	30 days	Incidence of postoperative complications and identify the associated risk factors.

Secondary Outcome Measures

Name	Time	Method
Cognitive Dysfunction	30 days	the incidence of cognitive dysfunction based on Mini Mental Status Examination

Trial Locations

Locations (2)

Hospital Universitari de Girona Dr. Josep Trueta; 🇪🇸 Girona, Catalonia, Spain

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States