Carotid Plaque Length to Predict Cardiovascular Events | NCT05409209

Studies
Carotid Plaque Length to Predict Cardiovascular Events

NCT05409209

Sponsor

Changhai Hospital

Status

Active, not recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Coronary Artery Disease

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

Jun 2022

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2030Estimated

First Submitted Date

Jun 3, 2022

First Submission Date that Met QC Criteria

Jun 3, 2022

First Posted Date

Jun 8, 2022Actual

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

Sep 8, 2024

Last Update Posted Date

Sep 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pan Li, Clinical Professor, Changhai HospitalPrincipal Investigator

Lead Sponsor

Changhai HospitalOTHER

Collaborators

Name	Class
Putuo Hospital, Shanghai University of Traditional Chinese Medicine	UNKNOWN
904th Hospital of the Joint Logistics Support Force of the PLA	OTHER
Gongli Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This multicenter study involved 5 hospitals (Changhai Hospital; Yueyang Hospital of Shanghai University of Traditional Chinese Medicine; Gongli Hospital; Putuo Hospital of Shanghai University of Traditional Chinese Medicine; No. 904 Hospital of the PLA Joint Logistics Support Force Wuxi). The study enrolled 3000 patients for suspected CAD who referred to coronary angiography from January 2017 through December 2018.

Detailed Description

Patients with coronary artery disease who were confirmed by coronary angiography were eligible for the study. Carotid ultrasonography was performed before coronary angiography, and carotid intima-media thickness (IMT), maximum thickness and length of all plaques were measured.

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

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carotid plaque length		Patients underwent carotid ultrasonography and first coronary angiography simultaneously

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
major cardiovascular event	A composite of cardiovascular death, myocardial infarction, and ischemic stroke	3 years

Secondary Outcomes

Measure	Description	Time Frame
major vascular event	A composite of cardiovascular death, myocardial infarction, ischemic stroke, and coronary artery revascularization	3 years
all-cause death		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients≥18 years old, those who underwent carotid ultrasonography and first coronary angiography simultaneously.

Exclusion Criteria:

Patients with known coronary artery disease, previous coronary or carotid revascularization, missing carotid ultrasound or coronary angiography results.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients hospitalized for first coronary angiography and underwent carotid ultrasonography simultaneously

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pan Li, PhD	Changhai Hospital	Principal Investigator
Jian Na, MD	Putuo Hospital	Study Director
Liang Chen, MD	904th Hospital of the Joint Logistics Support Force of the PLA	Study Director
Wei Zhang, MD	Gongli Hospital	Study Director
Yawei Yang, MD	Yueyang Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
No. 904 Hospital of the PLA Joint Logistics Support Force		Wuxi	Jiangsu	214000	China
Changhai Hospital

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

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided