Risk Factors for Complications After Carotid Endarterectomy

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03788980

Enrollment

Registered

2018-12-28

Start date

2018-04-13

Completion date

2019-07-09

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Cognitive Dysfunction, Postoperative Complications

Keywords

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.

Interventions

PROCEDURECarotid endarterectomy

Patients will undergo a surgery called carotid endarterectomy where a surgeon will remove material that causes carotid stenosis (i.e. plaque)

DIAGNOSTIC_TESTMini Mental Status Examination

Short questionnaire used to diagnose cognitive dysfunction

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026