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

Carotid Artery Plaque Clinical Trial

Official title:

Vascular Surgery Department of Beijing Tsinghua Chang Gung Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820207
• Other study ID #: (2016)003
• Status: Completed
• Start date: January 13, 2016
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Plaque
• Carotid Stenosis
• Ultrasonic Diagnosis

Locations

Country	Name	City	State
China	Beijing Tsinghua Chang Gung Hosipital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of ischemia shock	The incidence of ischemic stroke was defined as the number of cases of postoperative cerebral infarction divided by the total number of cases	within 30 days after operations
Secondary	the incidence of restenosis	the loss of lumen of carotid beyond 70% is defined as restenosis	6 months after operations
Secondary	the incidence of all-cause mortality	All-cause mortality includes all causes of death, such as MI, heart failure, stroke, bleeding et al.	within 30 days after operations