Clinical trial NCT03788980: Risk Factors for Complications After Carotid Endarterectomy
Official title: Risk Factors for Complications After Carotid Endarterectomy: A Multicenter International Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Postoperative Complications
Postoperative Cognitive Dysfunction
Keywords: Endarterectomy
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
First posted: 2018-12-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years of age or older scheduled to undergo carotid endarterectomy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complication rate
timeFrame: 30 days
Secondary outcomes:
measure: Cognitive Dysfunction
timeFrame: 30 days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta
state: Catalonia
Study officials:
affiliation: The Ohio State University Wexner Medical Center Department of Anesthesiology
name: Sergio Bergese, MD
role: PRINCIPAL_INVESTIGATOR
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