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

NCT ID: NCT02820207

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-13

Study Completion Date

2020-06-30

Brief Summary

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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

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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.

Conditions

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Carotid Artery Plaque Ultrasonic Diagnosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role lead

Responsible Party

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Keqiang Zhao

Attending Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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sifan Yang, M.D.

Role: STUDY_DIRECTOR

Beijing Tsinghua Chang Gung Hospital

Locations

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Beijing Tsinghua Chang Gung Hosipital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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(2016)003

Identifier Type: -

Identifier Source: org_study_id

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