Risk Prediction of Carotid Endarterectomy by Vascular Ultrasound Evaluation

Quantitative Prediction of Carotid Endarterectomy Risk Based on Vascular Structure and Hemodynamics by Vascular Ultrasound Evaluation System

Carotid endarterectomy (CEA) is one of the surgical treatment methods for the reconstruction of arterial stenosis or occlusion. Perioperative stroke, cerebral hemorrhage,hyperperfusion syndrome and death are main complications of CEA. Investigator have established a risk prediction model of the procedure based on vascular characteristics and hemodynamic parameters retrospectively. This prospective study was aimed to verify the predictive ability of CEA comprehensive prediction model through the analysis of patients receiving CEA procedure in the investigator's center in the next two years.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Procedure: CEA surgery

Detailed Description

Subjects: In this study, a total of 600-800 patients with severe carotid artery stenosis or occlusion who scheduled for CEA are recruited.

Data collection:

1. The plaque characteristics, stenosis degrees of carotid artery and intracranial arteries, and collateral circulation are evaluated by ultrasound prior to the procedure.
2. CT, MRI and digital subtraction angiography (DSA) were applied pre- and post-procedure to identify the clinical events.

Endpoint: The combination endpoints events of death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome within 30-day after the procedure.

Statistical analysis plans: The Statistical Package of Social Sciences (SPSS version 22.0) software are used for statistical analysis. The area under the receiver operating characteristic (ROC) curve and hosmer-lemeshow test were used to evaluate the discrimination and calibration of the risk prediction model.

• Study Type: Observational
• Enrollment (Actual): 1498

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with carotid artery severe (70-99%) stenosis or occlusion who are scheduled for CEA.

Description

Inclusion Criteria:

1. Patients with carotid artery severe (70-99%) stenosis or occlusion diagnosed by color duplex flow imaging (CDFI) and confirmed by CT angiography (CTA) or digital subtraction angiography (DSA).
2. Patient has the indications for carotid artery stenting or CEA according to the guidelines published by the Stroke Prevention Engineering Committee, the National Health Commission of China.
3. MRI and CT were applicated pre- and postoperation.

Exclusion Criteria:

1. Patients with non-atherosclerotic carotid artery stenosis or occlusion, such as dissection, aneurysm, arteritis, cardiac embolism, et al.
2. Lack of any imaging evaluation results, such as ultrasound, MRI or CT.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of death, stroke or hemorrhage	The rate of combination endpoints events of death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome.	30 days postoperation

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Ultrasound; Carotid Endarterectomy; Risk Prediction Model
• Other Study ID Numbers: VUS-CEA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No