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

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

Study Description
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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
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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Vascular Surgery Department of Beijing Tsinghua Chang Gung Hospital
Actual Study Start Date : January 13, 2016
Actual Primary Completion Date : November 30, 2019
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Plague Ultrasound

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. the incidence of restenosis [ Time Frame: 6 months after operations ]
    the loss of lumen of carotid beyond 70% is defined as restenosis

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
the patients suffering from carotid artery stenosis
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820207


Locations
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China, Beijing
Beijing Tsinghua Chang Gung Hosipital
Beijing, Beijing, China, 102218
Sponsors and Collaborators
Beijing Tsinghua Chang Gung Hospital
Investigators
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Study Director: sifan Yang, M.D. Beijing Tsinghua Chang Gung Hospital
More Information
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Additional Information:

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Responsible Party: Zhao Keqiang, Attending Doctor, Beijing Tsinghua Chang Gung Hospital
ClinicalTrials.gov Identifier: NCT02820207    
Other Study ID Numbers: （2016）003
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zhao Keqiang, Beijing Tsinghua Chang Gung Hospital:
Carotid Artery Plaque
Contrast Enhanced Ultrasound
Plague Histopathology
Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases