NCT03785626

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,498 (actual)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Stroke

Interventions

Type	Name	Description
PROCEDURE	CEA surgery	patients with carotid artery severe (70-99%) stenosis or occlusion received CEA surgery

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2018-12-24
• Last updated: 2022-07-18

Locations

1 site across 1 country: China