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NCT Number: NCT02820207

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

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.

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Key information

Conditions

Carotid Artery Plaque Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Ultrasonic Diagnosis Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tsinghua Chang Gung Hosipital

Beijing, Beijing Municipality, 102218, China

About this study

  • 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.
  • 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.
  • To evaluate the accuracy of CEUS for identifying carotid vulnerable plague compared with high resolution MR.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Official study title

Vascular Surgery Department of Beijing Tsinghua Chang Gung Hospital

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jun 30, 2016
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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