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

Sponsor
Beijing Tsinghua Chang Gung Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02820207
Collaborator
(none)
50
1
53.6
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Vascular Surgery Department of Beijing Tsinghua Chang Gung Hospital
    Actual Study Start Date :
    Jan 13, 2016
    Actual Primary Completion Date :
    Nov 30, 2019
    Actual Study Completion Date :
    Jun 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. the incidence of restenosis [6 months after operations]

      the loss of lumen of carotid beyond 70% is defined as restenosis

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Tsinghua Chang Gung Hosipital Beijing Beijing China 102218

    Sponsors and Collaborators

    • Beijing Tsinghua Chang Gung Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Keqiang Zhao, Attending Doctor, Beijing Tsinghua Chang Gung Hospital
    ClinicalTrials.gov Identifier:
    NCT02820207
    Other Study ID Numbers:
    • (2016)003
    First Posted:
    Jun 30, 2016
    Last Update Posted:
    Feb 1, 2021
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Keqiang Zhao, Attending Doctor, Beijing Tsinghua Chang Gung Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 1, 2021