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Risk Factors for Complications After Carotid Endarterectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788980
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : August 29, 2019
Sponsor:
Collaborator:
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Information provided by (Responsible Party):
Sergio Bergese, 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).

Condition or disease Intervention/treatment
Postoperative Complications Postoperative Cognitive Dysfunction Procedure: Carotid endarterectomy Diagnostic Test: Mini Mental Status Examination

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.

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Study Type : Observational
Estimated Enrollment : 354 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Risk Factors for Complications After Carotid Endarterectomy: A Multicenter International Observational Study
Actual Study Start Date : April 13, 2018
Estimated Primary Completion Date : April 13, 2020
Estimated Study Completion Date : April 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Group/Cohort Intervention/treatment
carotid endarterectomy group
patients undergoing carotid endarterectomy
Procedure: Carotid endarterectomy
Patients will undergo a surgery called carotid endarterectomy where a surgeon will remove material that causes carotid stenosis (i.e. plaque)
Other Name: CAE

Diagnostic Test: Mini Mental Status Examination
Short questionnaire used to diagnose cognitive dysfunction
Other Name: MMSE




Primary Outcome Measures :
  1. Complication rate [ Time Frame: 30 days ]
    Incidence of postoperative complications and identify the associated risk factors.


Secondary Outcome Measures :
  1. Cognitive Dysfunction [ Time Frame: 30 days ]
    the incidence of cognitive dysfunction based on Mini Mental Status Examination



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients 18 years of age or older scheduled to undergo carotid endarterectomy
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788980


Contacts
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Contact: Juan Fiorda, MD 614-293-3559 juan.fiorda@osumc.edu
Contact: Alberto Uribe, MD 614-293-3559 alberto.uribe@osumc.edu

Locations
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United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Alberto Uribe, MD    614-293-3559    Alberto.Uribe@osumc.edu   
Principal Investigator: Sergio Bergese, MD         
Spain
Hospital Universitari de Girona Dr. Josep Trueta Recruiting
Girona, Catalonia, Spain, 17007
Contact: Marc Vives, MD       marcvives50@gmail.com   
Contact: Bernat Lloret, MD       bernatlloret@gmail.com   
Sponsors and Collaborators
Ohio State University
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Investigators
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Principal Investigator: Sergio Bergese, MD The Ohio State University Wexner Medical Center Department of Anesthesiology

Publications:

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Responsible Party: Sergio Bergese, Professor-Clinical, Ohio State University
ClinicalTrials.gov Identifier: NCT03788980    
Other Study ID Numbers: 2018H0044
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sergio Bergese, Ohio State University:
Endarterectomy
Additional relevant MeSH terms:
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Postoperative Complications
Cognitive Dysfunction
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders