Risk Factors for Complications After Carotid Endarterectomy

September 29, 2023 updated by: Ohio State University

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).

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Catalonia
      • Girona, Catalonia, Spain, 17007
        • Hospital Universitari de Girona Dr. Josep Trueta
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients 18 years of age or older scheduled to undergo carotid endarterectomy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
carotid endarterectomy group
patients undergoing carotid endarterectomy
Patients will undergo a surgery called carotid endarterectomy where a surgeon will remove material that causes carotid stenosis (i.e. plaque)
Other Names:
  • CAE
Short questionnaire used to diagnose cognitive dysfunction
Other Names:
  • MMSE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sergio Bergese, MD, The Ohio State University Wexner Medical Center Department of Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2018

Primary Completion (Actual)

July 9, 2019

Study Completion (Actual)

July 9, 2019

Study Registration Dates

First Submitted

December 26, 2018

First Submitted That Met QC Criteria

December 26, 2018

First Posted (Actual)

December 28, 2018

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 29, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The de-identified date from the international site and the data collected at the main site will be analyzed at The Ohio State University Wexner Medical Center.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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