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

Vascular Surgery Department of Beijing Tsinghua Chang Gung Hospital

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.

Study Overview

• Status: Completed
• Conditions: Carotid Artery Plaque; Ultrasonic Diagnosis

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 102218
      • Beijing Tsinghua Chang Gung Hosipital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

the patients suffering from carotid artery stenosis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Vulnerable plague; The patients suffering from carotid artery stenosis were identified as the vulnerable plague group by Contrast Enhanced Ultrasound whose plagues were found intraplaque neovascularization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of restenosis	the loss of lumen of carotid beyond 70% is defined as restenosis	6 months after operations
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

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital
• Investigators: Study Director: sifan Yang, M.D., Beijing Tsinghua Chang Gung Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2016
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Carotid Artery Plaque; Contrast Enhanced Ultrasound; Plague Histopathology
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: （2016）003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No