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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01416532
First Posted: August 15, 2011
Last Update Posted: August 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Seoul National University Bundang Hospital
  Purpose
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).

Condition
Coronary Atherosclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Estimated Enrollment: 5000
Study Start Date: January 2006
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Asymptomatic adults without previous coronary artery disease
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416532


Locations
Korea, Republic of
Seound National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 436-707
Contact: Eun Ju Chun, MD, PhD    82-31-787-7618    drejchun@hanmail.net   
Principal Investigator: Eun Ju Chun, MD, PhD         
Sub-Investigator: Sang Il Choi, MD, PhD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Study Director: Eun Ju Chun, MD, PhD Seoul National University Bundang Hospital
  More Information

Responsible Party: Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01416532     History of Changes
Other Study ID Numbers: B-1107-131-104
First Submitted: August 12, 2011
First Posted: August 15, 2011
Last Update Posted: August 18, 2011
Last Verified: July 2011

Keywords provided by Seoul National University Bundang Hospital:
coronary Atheroslcerosis
Computed Tomography

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases