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

NCT02820207 | Completed DMC

• 1 other identifier: （2016）003
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Plaque; Ultrasonic Diagnosis

Keywords

Carotid Artery Plaque; Contrast Enhanced Ultrasound; Plague Histopathology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• the incidence of restenosis

  6 months after operations

• the incidence of all-cause mortality

  within 30 days after operations

Study Arms (1)

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

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the patients suffering from carotid artery stenosis

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Chang Gung Hosipital

Beijing, Beijing Municipality, 102218, China

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• sifan Yang, M.D.

  Beijing Tsinghua Chang Gung Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 30, 2016
• Study Start: January 13, 2016
• Primary Completion: November 30, 2019
• Study Completion: June 30, 2020
• Last Updated: February 1, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)