Risk Factors for Complications After Carotid Endarterectomy



Status:Recruiting
Conditions:Cognitive Studies, Hospital
Therapuetic Areas:Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - Any
Updated:2/9/2019
Start Date:April 13, 2018
End Date:April 13, 2020
Contact:January K Kim, BS
Email:January.Kim@osumc.edu
Phone:6142933559

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

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).

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.

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
We found this trial at
2
sites
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Sergio Bergese, MD
Phone: 614-293-3559
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Columbus, OH
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Girona,
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