Viewing Study NCT01416532


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Study NCT ID: NCT01416532
Status: UNKNOWN
Last Update Posted: 2011-08-18
First Post: 2011-08-12
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Evaluation of Subclinical COronary Atherosclerosis for Risk Stratification Using Coronary Computed Tomography (CT) Angiography
Sponsor: Seoul National University Bundang Hospital
Organization:

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2011-07
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ESCORT
Brief 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).
Detailed 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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: