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

Completed

• Conditions: Ultrasonic Diagnosis; Carotid Artery Plaque

• Registration Number: NCT02820207
• Lead Sponsor: 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 Description

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.

Study Timeline

• Study Start: 2016-01-13
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-06-30
• Primary Completion: 2019-11-30
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• The patients with ischemic symptom whose carotid stenosis were more than 50%
• The patients without ischemic symptom whose carotid stenosis were more than 70%

Exclusion Criteria

• Confirmed with severe intracranial vascular lesions
• Suffering from the large area cerebral infarction or critical stroke sequela
• Restenosis after CEA or CAS
• Suffering from severe coronary heart disease, respiratory failure,the hypertension difficult to controled
• Patients with malignant tumor or expected life < 2 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the incidence of ischemia shock	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

Secondary Outcome Measures

Name	Time	Method
the incidence of restenosis	6 months after operations	the loss of lumen of carotid beyond 70% is defined as restenosis
the incidence of all-cause mortality	within 30 days after operations	All-cause mortality includes all causes of death, such as MI, heart failure, stroke, bleeding et al.

Trial Locations

Locations (1)

Beijing Tsinghua Chang Gung Hosipital; 🇨🇳 Beijing, Beijing, China