Korea Atherosclerosis Study-3 | NCT01168362

Studies
Korea Atherosclerosis Study-3

NCT01168362

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Oct 25, 2013Estimated

Enrollment

4,000Actual

Phase

Not provided

Conditions

Cardiovascular Diseases
Cardiovascular Mortality
All-cause Mortality

Interventions

Not provided

Countries

South Korea

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

Oct 2013

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

Feb 2006

Primary Completion Date

Mar 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Jul 22, 2010

First Submission Date that Met QC Criteria

Jul 22, 2010

First Posted Date

Jul 23, 2010Estimated

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

Oct 24, 2013

Last Update Posted Date

Oct 25, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Soo Lim, Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Multidetector-row Computed Tomography (CT) has been introduced for use in the diagnosis of coronary heart disease. The investigators aimed to characterize coronary artery disease in subjects with cardiovascular risk or not, and in particular plaque natures depending on different status of cardiovascular risk. Especially,the investigators will evaluate the relationships between the pericardial fat and severity of stenosis as well as plaque characteristics using logistic regression models.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

4,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High risk group		positive cardiovascular risk group
Low risk group		negative cardiovascular risk group

Interventions

Not provided

Measure	Description	Time Frame
Presence of coronary artery disease		5 years

Measure	Description	Time Frame
Mortality		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Korean capable of Multidetector-Row Cardiac Computed Tomography (MDCT)

Exclusion Criteria:

malignancy
infection
shock

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

positive cardiovascular risks or not

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Soo Lim, MD,PHD	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D001161	Arteriosclerosis

Browse Leaves

Not provided

Browse Branches

Not provided