Evaluation of Subclinical COronary Atherosclerosis for Risk Stratification Using Coronary Computed Tomography (CT) Angiography

Coronary Atherosclerosis Clinical Trial

— ESCORT  

Official title:

Prognostic Value of Coronary CT Angiography in Relation to Evaluation of Subclinical Coronary Atherosclerosis for Risk Stratification in Asymptomatic Individuals From ESCORT Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01416532
• Other study ID #: B-1107-131-104
• Status: Recruiting
• Phase: N/A
• First received: August 12, 2011
• Last updated: August 17, 2011
• Start date: January 2006
• Est. completion date: December 2015

Study information

• Verified date: July 2011
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

To evaluate the prognostic value of coronary CT angiography (CCTA) for risk stratification in asymptomatic adults in comparison with conventional risk stratification (CRS) and coronary artery calcium scoring (CACS).

Description:

The risk stratification of cardiovascular disease (CVD) in asymptomatic individuals represents a major challenge. For this purpose, a lot of risk prediction models that take demographic and clinical characteristics into account have been developed. Although Framingham risk score (FRS) is most widely used among multiplr risk prediction models, it has some limitation for prediction of CVD especially in young adult and women. Recently, coronary artery calcium score (CACS) has known to be powerful screening method for CVD, however, it cannot detect the noncalcified coronary plaques (NCP), so it does not represent the entire spectrum of atherosclerotic plaques and it also cannot evaluate the degree of stenosis. On the contrary, Coronary CT angiography (CCTA)can provide detailed coronary artery anatomy and plaque imaging about the location, burden and characteristics of atherosclerotic plaque per se, which might give additional insight to stratify the risk of future cardiac events and therapy.

In this study, we will evaluate the prevalence and characteristics of subclinical coronary atherosclerosis on CCTA in asymptomatic population. And we will investiage the follow up data for major cardiac adverse event such as cardiac death, nonfatal myocardial infarction, unstable angina and revascularization. Therefore, we will finally evaluate the prognostic value of CCTA for risk stratification in asymptomatic adults in comparsion with conventional risk stratification such as FRS and CACS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2015
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• asymptomatic subjects

• adults > 20 years

• subjects who underwent both calcium score and coronary CT angiography

Exclusion Criteria:

• typical or atypical chest pain

• subjects who underwent previous percutaneous coronary intervention

• serious comorbid conditions(i.e. malignancy)

• insufficient medical record

• poor image quality

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Myocardial Ischemia

Locations

Country	Name	City	State
Korea, Republic of	Seound National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of,