Risk Prediction of Carotid Endarterectomy by Vascular Ultrasound Evaluation

NCT03785626 | Completed

• 1 other identifier: VUS-CEA
• Study Type: observational
• Target: 1,498
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Ultrasound; Carotid Endarterectomy; Risk Prediction Model

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

CEA surgery PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).
• 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.
• MRI and CT were applicated pre- and postoperation.

You may not qualify if:

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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)