Clinical trial NCT02820207: Identification of Carotid Plague Vulnerability by Contrast Enhanced Ultrasound: Correlation With Plague Histopathology
Official title: Vascular Surgery Department of Beijing Tsinghua Chang Gung Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carotid Artery Plaque
Ultrasonic Diagnosis
Keywords: Carotid Artery Plaque
Contrast Enhanced Ultrasound
Plague Histopathology
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the patients suffering from carotid artery stenosis

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.

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

Primary outcomes:
measure: the incidence of ischemia shock
timeFrame: within 30 days after operations
Secondary outcomes:
measure: the incidence of restenosis
timeFrame: 6 months after operations
measure: the incidence of all-cause mortality
timeFrame: within 30 days after operations
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Chang Gung Hosipital
state: Beijing
Study officials:
affiliation: Beijing Tsinghua Chang Gung Hospital
name: sifan Yang, M.D.
role: STUDY_DIRECTOR
References: