Ultrasound Evaluation of Carotid Artery Atherosclerotic Plaques and Recanalization
Condition: Stroke
MeSH terms: Plaque, Atherosclerotic
Study type: Observational

Summary: 
      The purpose of this multiple-center study are: 1) To establish the ultrasound criteria for
      evaluating vulnerable plaques by comparing the plaque echo characteristics before CEA
      (carotid artery endarterectomy) and plaque specimen after CEA.

      2) To establish the carotid artery recanalization strategies based on the evaluation results
      of carotid artery and intracranial artery by color doppler flow imaging and TCCS/TCD
      (transcranial color coded sonography/transcranial doppler).

      3) To compare the success rate and the incidence of restenosis between CEA and carotid artery
      stenting.
    

Detailed description: 
      In this study, a total of 1000-1200 patients with carotid artery moderate (50-69%, with
      symptoms), severe (70-99%) stenosis (with or without symptoms) or occlusion who received
      either CEA or stenting are to recruited. Before carotid artery recanalization, CDFI (color
      duplex flow imaging) and TCCS/TCD are used to evaluate the structures and hemodynamic of
      carotid artery and intracranial artery. In addition, patients are to be followed up by
      ultrasound 1 week, 3 month, 6month and 1 year after recanalization.

        1. Ultrasound examinations procedures: According to the guidelines of vascular
           ultrasonography published by the Stroke Prevention Engineering Committee, the National
           Health Commission of China in 2015. The plaque characteristics, stenosis degrees of
           carotid artery and intracranial arteries, and collateral circulation are evaluated by
           CDFI and TCCS/TCD.

        2. Radiology examination procedures: Before recanalization, enrolled patients receive MRI
           examinations to determine the presence and the location of cerebral infarction. If
           necessary, patients receive CT angiography (CTA) , MRI angiography (MRA) or Digital
           subtraction angiography (DSA) to confirm the degrees of vessel stenosis and occlusion.
           One week after recanalization, CT and MRI are used to identify the cerebral hemorrhage
           and newly cerebral infarction.

        3. The data collected in this study including:

      1) The general information of enrolled subjects, which include age, gender, resident address
      and telephone number, the history of hypertension, coronary artery diseases, dyslipidemia,
      diabetes mellitus and smoking.

      2. The primary endpoints are: The combination endpoints events of death, cerebral hemorrhage
      , newly cerebral infarction, hyperperfusion syndrome, residual sternosis≥50% within 30-day
      after recanalization. The secondary endpoints are the re-current cerebral artery events and
      the occurence of restenosis during the at least 1 year follow-up period.

      4. Statistical analysis plans: The Statistical Package of Social Sciences (SPSS version 22.0)
      software are used for statistical analysis.

      1) Diagnostic test are used to test the sensitivity, specificity and accuracy of ultrasound
      for evaluating vulnerable plaque by using plaque specimen after CEA as the "gold" standard.

      2) The Chi-square test are used to compare the success rate of stenting and CEA. The Cox
      regression analysis are used to compare the restenosis rate of stenting and CEA.

      3) A P<0.05 was considered statistically significance. 5. Quality assurance plan:

        1. The medical centers implement the projects are the stroke center awarded by the Stroke
           Prevention Engineering Committee, the National Health Commission of China. The medical
           centers have the instruments required in this study.

        2. Neurologists, neurosurgeons and vascular ultrasound physicians have received standard
           training hosted by the Stroke Prevention Engineering Committee, the National Health
           Commission of China and obtained excellent records.

        3. All the centers conduct the project followed the uniform implementation plans and each
           center guarantee the data input in time and accurately.

        4. The project has the unique database and data input in uniform format.

        5. There are specific staffs to check the accuracy and completeness of data.
    

Intervention name(s): Carotid artery recanalization CEA or carotid artery stenting
Intervention type(s): Procedure
Intervention description(s): Carotid artery recanalization CEA or carotid artery stenting
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with carotid artery moderate (50-69%), severe (70-99%) stenosis or occlusion, who
        needs recanalization by CEA or stenting.
      
Biospecimen description: 
      Carotid artery plaques removed by CEA.
    
Keywords: Stroke; Ischemia; Carotid artery Stenosis; CEA; Stenting; Ultrasound; Vulnerable plaque