Risk Factors for Complications After Carotid Endarterectomy

The Ohio State University

Status: Terminated

Conditions: Postoperative Complications; Postoperative Cognitive Dysfunction

Treatments: Procedure: Carotid endarterectomy; Diagnostic Test: Mini Mental Status Examination

Study type: Observational

Funder types: Other

Identifiers

NCT03788980

2018H0044

Details and patient eligibility

About

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).

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

10 participants in 1 patient group

carotid endarterectomy group

Description:

patients undergoing carotid endarterectomy

Treatment:

Diagnostic Test: Mini Mental Status Examination

Procedure: Carotid endarterectomy