Carotid Atherosclerosis in Predicting Coronary Artery Dis... | NCT06253962

Studies
Carotid Atherosclerosis in Predicting Coronary Artery Disease

NCT06253962

Sponsor

Shanghai Zhongshan Hospital

Status

Recruiting

Last Update Posted

Feb 12, 2024Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Carotid Atherosclerosis
Coronary Atheroscleroses

Interventions

coronary agiongraphy

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

Feb 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2024Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Feb 4, 2024

First Submission Date that Met QC Criteria

Feb 4, 2024

First Posted Date

Feb 12, 2024Actual

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

Feb 4, 2024

Last Update Posted Date

Feb 12, 2024Actual

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

Carotid plaque burden and composition features, particularly lipid necrotic core, are significantly associated with severity of CAD stenosis. This study aims to explore the relationship between various phenotypic patterns of carotid atherosclerosis with the prevalence, phenotype, and severity of coronary atherosclerosis. The patients with chest tightness or chest pain will receive carotid artery ultrasonography before coronary angiography so as to explore the relationship between them.

Detailed Description

Not provided

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

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
carotid atherosclerosis			Other: coronary agiongraphy
without carotid atherosclerosis			Other: coronary agiongraphy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
coronary agiongraphy	Other	severity of coronary atherosclerosis	carotid atherosclerosis without carotid atherosclerosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MACE	acute myocardial infarction; heart failure; cardiac death; revascularization	two years after angiography

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients receive carotid ultrasound and coronary angiography

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients admitted to receive coronary angiography. Carotid ultrasound performed before angiography.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Danbo Lu, PhD	Contact	+86 021 64041990		lu.danbo@zs-hospital.sh.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
180 Fenglin Road	Recruiting	Shanghai		200032	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

Condition Browse Module

MeSH Terms

ID	Term
D002340	Carotid Artery Diseases
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided