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

• ClinicalTrials.gov Identifier: NCT02820207
• Recruitment Status: Completed
• First Posted: June 30, 2016
• Last Update Posted: July 24, 2020
• Sponsor: Beijing Tsinghua Chang Gung Hospital
• Information provided by (Responsible Party): Zhao Keqiang, Beijing Tsinghua Chang Gung Hospital

Tracking Information

• First Submitted Date: June 20, 2016
• First Posted Date: June 30, 2016
• Last Update Posted Date: July 24, 2020
• Actual Study Start Date: January 13, 2016
• Actual Primary Completion Date: November 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 19, 2017)

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

• Original Primary Outcome Measures (submitted: June 29, 2016): the incidence of ischemia shock [ Time Frame: within 30 days after operations ]

Current Secondary Outcome Measures (submitted: July 19, 2017)

• 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.

Original Secondary Outcome Measures (submitted: June 29, 2016)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Identification of Carotid Plague Vulnerability by Contrast Enhanced Ultrasound: Correlation With Plague Histopathology
• 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 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 [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 6 Months
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: the patients suffering from carotid artery stenosis

Condition

• Carotid Artery Plaque
• Ultrasonic Diagnosis

• Intervention: Not Provided

Study Groups/Cohorts

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 29, 2016): 50
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 30, 2020
• Actual Primary Completion Date: November 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02820207
• Other Study ID Numbers: （2016）003
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Zhao Keqiang, Beijing Tsinghua Chang Gung Hospital
• Study Sponsor: Beijing Tsinghua Chang Gung Hospital
• Collaborators: Not Provided

Investigators

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

• PRS Account: Beijing Tsinghua Chang Gung Hospital
• Verification Date: July 2020