Clinical Trial: Identification of Carotid Plague Vulnerability by Contrast Enhanced Ultrasound: Correlation With Plague Histopathology

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Vascular Surgery Department of Beijing Tsinghua Chang Gung Hospital

Brief Summary:

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.


Detailed Summary:

  1. 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.
  2. 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.
  3. To evaluate the accuracy of CEUS for identifying carotid vulnerable plague compared with high resolution MR.
  4. 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.

Sponsor: Beijing Tsinghua Chang Gung Hospital

Current Primary Outcome: the incidence of ischemia shock [ Time Frame: within 30 days after operations ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • the incidence of restenosis [ Time Frame: 6 months after operations ]
  • the incidence of all-cause mortality [ Time Frame: within 30 days after operations ]


Original Secondary Outcome: Same as current

Information By: Beijing Tsinghua Chang Gung Hospital

Dates:
Date Received: June 20, 2016
Date Started: January 2016
Date Completion: June 2018
Last Updated: July 5, 2016
Last Verified: June 2016