Evaluation of the Vulnerable Carotid Atherosclerotic Plaq... | NCT05849909

Studies
Evaluation of the Vulnerable Carotid Atherosclerotic Plaque: A Clinical Multicenter Study

NCT05849909

Sponsor

huang pintong

Status

Unknown status

Last Update Posted

May 9, 2023Actual

Enrollment

57Estimated

Phase

Not provided

Conditions

Ultrasound

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

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 18, 2023Actual

Primary Completion Date

Apr 20, 2023Actual

Completion Date

Apr 18, 2024Estimated

First Submitted Date

Apr 28, 2023

First Submission Date that Met QC Criteria

Apr 28, 2023

First Posted Date

May 9, 2023Actual

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

Apr 28, 2023

Last Update Posted Date

May 9, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

huang pintong, Director of Ultrasound Department, Second Affiliated Hospital, School of Medicine, Zhejiang UniversitySponsor-Investigator

Lead Sponsor

huang pintongOTHER

Collaborators

Name	Class
Second Affiliated Hospital, School of Medicine, Zhejiang University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Evaluation of carotid plaque vulnerability based on ultrasound imaging features， proteomics and metabolomics: a clinical multicenter study

Detailed Description

Carotid artery plaque tissue specimen for proteomics. Blood were collect for metabolomics.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

57Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ultrasound	B mode	2023.05

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who meet the CEA surgical indications;
Age>18 years old;
Patients who sign informed consent forms

Exclusion Criteria:

Those with severe calcification of plaques and obvious acoustic shadows, and poor image quality;
Contraindications to ultrasound contrast, such as those who are allergic to contrast agents;
Intracardiac right to left shunt;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients undergoing carotid endarterectomy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University	Recruiting	Hangzhou	Zhejiang	310000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Label	Type	Description	Intervention Names
Stable Carotid Atherosclerotic Plaques
Unstable Carotid Atherosclerotic Plaques