NCT01168362

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

October 25, 2013

Status Verified

October 1, 2013

Enrollment Period

7.1 years

First QC Date

July 22, 2010

Last Update Submit

October 24, 2013

Conditions

Cardiovascular DiseasesCardiovascular MortalityAll-cause Mortality

Keywords

coronary artery diseasecardiovascular riskpericardial fat

Outcome Measures

Primary Outcomes (1)

  • Presence of coronary artery disease

    5 years

Secondary Outcomes (1)

  • Mortality

    5 years

Study Arms (2)

High risk group

positive cardiovascular risk group

Low risk group

negative cardiovascular risk group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

positive cardiovascular risks or not

You may qualify if:

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

You may not qualify if:

  • malignancy
  • infection
  • shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biochemical paramteres including lipid, glucose, insulin, and other novel cardiometabolic factors

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Soo Lim, MD,PHD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 22, 2010

First Posted

July 23, 2010

Study Start

February 1, 2006

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

October 25, 2013

Record last verified: 2013-10

Locations

KR(1)