Identification of Carotid Plague Vulnerability by Contras... | NCT02820207

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

NCT02820207

Sponsor

Beijing Tsinghua Chang Gung Hospital

Status

Completed

Last Update Posted

Feb 1, 2021Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Carotid Artery Plaque
Ultrasonic Diagnosis

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 13, 2016Actual

Primary Completion Date

Nov 30, 2019Actual

Completion Date

Jun 30, 2020Actual

First Submitted Date

Jun 20, 2016

First Submission Date that Met QC Criteria

Jun 29, 2016

First Posted Date

Jun 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2021

Last Update Posted Date

Feb 1, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Keqiang Zhao, Attending Doctor, Beijing Tsinghua Chang Gung HospitalPrincipal Investigator

Lead Sponsor

Beijing Tsinghua Chang Gung HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the incidence of ischemia shock	The incidence of ischemic stroke was defined as the number of cases of postoperative cerebral infarction divided by the total number of cases	within 30 days after operations

Secondary Outcomes

Measure	Description	Time Frame
the incidence of restenosis	the loss of lumen of carotid beyond 70% is defined as restenosis	6 months after operations
the incidence of all-cause mortality	All-cause mortality includes all causes of death, such as MI, heart failure, stroke, bleeding et al.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

the patients suffering from carotid artery stenosis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
sifan Yang, M.D.	Beijing Tsinghua Chang Gung Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tsinghua Chang Gung Hosipital		Beijing	Beijing Municipality	102218	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016893	Carotid Stenosis

Ancestor Terms

ID	Term
D002340	Carotid Artery Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

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