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OpenTrials
Completed

NCT Number: NCT03785626

Risk Prediction of Carotid Endarterectomy by Vascular Ultrasound Evaluation

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

About this study

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:

  • The plaque characteristics, stenosis degrees of carotid artery and intracranial arteries, and collateral circulation are evaluated by ultrasound prior to the procedure.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

CEA surgery

Procedure

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

Primary outcomes

  1. The rate of death, stroke or hemorrhage

    Time frame: 30 days postoperation

    The rate of combination endpoints events of death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome.

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 24, 2018
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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