Identification of Carotid Plague Vulnerability by Contrast Enhanced Ultrasound: Correlation With Plague Histopathology
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|ClinicalTrials.gov Identifier: NCT02820207|
Recruitment Status : Completed
First Posted : June 30, 2016
Last Update Posted : July 24, 2020
OBJECTIVE/BACKGROUND: Intraplaque neovascularization is one of the most important risk factors for unstable carotid plaque. This study was designed to evaluate whether carotid intraplaque neovascularization (IPN) can be accurately assessed by contrast enhanced ultrasound (CEUS).
METHODS: Preoperative CEUS analysis of 50 carotid artery stenosis patients would be compared to histopathology performed on their plaques excised by carotid endarterectomy (CEA) with CD34 and MMP9 staining.
|Condition or disease|
|Carotid Artery Plaque Ultrasonic Diagnosis|
- To enroll 50 cases of patients suffering from carotid artery stenosis continuously, the investigators perform contrast enhanced ultrasound on patients for identifying the vulnerable plagues and taking high resolution MR inspection to analysis those plagues at the same time.
- All patients undergo carotid endarterectomy. The vulnerable ingredients of carotid plaques such as intraplaque neovascularization and bleeding are identified by pathological examination and immunohistochemical staining.
- To evaluate the accuracy of CEUS for identifying carotid vulnerable plague compared with high resolution MR.
- The investigators divide patients into the stable group and the vulnerable group based on the results of CEUS inspection. To analysis the incidence of postoperative complications such as stroke and mortality within 30 days and to compare the differences between the two groups.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||50 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Vascular Surgery Department of Beijing Tsinghua Chang Gung Hospital|
|Actual Study Start Date :||January 13, 2016|
|Actual Primary Completion Date :||November 30, 2019|
|Actual Study Completion Date :||June 30, 2020|
The patients suffering from carotid artery stenosis were identified as the vulnerable plague group by Contrast Enhanced Ultrasound whose plagues were found intraplaque neovascularization
- the incidence of ischemia shock [ Time Frame: within 30 days after operations ]The incidence of ischemic stroke was defined as the number of cases of postoperative cerebral infarction divided by the total number of cases
- the incidence of restenosis [ Time Frame: 6 months after operations ]the loss of lumen of carotid beyond 70% is defined as restenosis
- the incidence of all-cause mortality [ Time Frame: within 30 days after operations ]All-cause mortality includes all causes of death, such as MI, heart failure, stroke, bleeding et al.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820207
|Beijing Tsinghua Chang Gung Hosipital|
|Beijing, Beijing, China, 102218|
|Study Director:||sifan Yang, M.D.||Beijing Tsinghua Chang Gung Hospital|