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Subclinical COronary Atheroscleorosis Updated With Coronary cT Angiography (SCOUT Study)

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. Identifier: NCT00431860
Recruitment Status : Unknown
Verified May 2007 by Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
First Posted : February 6, 2007
Last Update Posted : May 3, 2007
Information provided by:
Seoul National University Bundang Hospital

Brief Summary:
The purpose of this study is to validate the usefulness of 64-slice multi-detecter computeted tomography as a screening tool in asymptomatic population.

Condition or disease Intervention/treatment
Coronary Atherosclerosis Procedure: Coronary computed tomographic angiography

Detailed Description:

A large proportion of patients with sudden cardiac death or nonfatal myocardial infarction (MI) had no prior symptom, which emphasizes the importance of early detection and treatment of the underlying subclinical coronary atherosclerosis before they happen. However, there are no powerful screening methods to detect subclinical coronary atherosclerosis until recently. Traditional CAD risk factors, treadmill exercise test, and EBCT are known to have limited power to detect subclinical coronary atherosclerosis and predict future cardiac events.

Coronary CT angiography (CTA) depicting detailed coronary artery anatomy in a noninvasive fashion would seem to be already one of the mainstays of diagnostic procedure in symptomatic population. Instead of the probability of significant stenosis, CTA could provide information 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 CTA and its impact on the management in asymptomatic population. And then, we will develop standardized protocol for the management of subclinical coronary atherosclerosis, and follow for adverse cardiac events.

In phase I study, we will enroll subjects who had undergone CTA and analyze the characteristics of plaques on CTA. Also, we will evaluate the impact of CTA by comparing the performance of secondary test with those who had not undergone CTA evaluation.

In phase II study, we will recruit subjects who had significant coronary stenosis on CTA. If the patients had significant stenosis, they will undergo coronary angiography to confirm the severity of stenosis. If they had coronary artery stenosis more than 75%, they will receive percutaneous coronary intervention with drug-eluting stent (DES). If they had intermediate lesion, their treatment option will be judged by the results of fractional flow reserve test. If they had coronary lesion less than 50%, they will be treated only by medication.

When the patients are eligible for study, investigators will give information about the study and obtain written consent. The presence of chest pain symptom will be screened with Rose questionnaire. Medical history and physical examination will be performed, and baseline laboratory work-up will be performed.

Following above treatment guidelines, all patients will be followed for adverse cardiac events for 5 years.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Subclinical COronary Atheroscleorosis Updated With Coronary cT Angiography (SCOUT Study)
Study Start Date : December 2005
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • asymptomatic subjects
  • 20-75 years
  • subjects who had undergone spiral coronary CT angiography for health check-up

Exclusion Criteria:

  • typical or atypical chest pain
  • serious comorbid conditions(i.e. malignancy)

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 identifier (NCT number): NCT00431860

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Contact: Huk-Jae Chang, MD, PhD 82-31-787-7024

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Korea, Republic of
Seoul National University Bundang hospital Recruiting
Sungnam-si, Kyungki-do, Korea, Republic of
Contact: Huk-Jae Chang, MD, PhD    82-32-787-7024   
Sponsors and Collaborators
Seoul National University Bundang Hospital
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Study Director: Huk-Jae Chang, MD, PhD Seoul National University Bundang Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00431860    
Other Study ID Numbers: B-0606/034-019
First Posted: February 6, 2007    Key Record Dates
Last Update Posted: May 3, 2007
Last Verified: May 2007
Keywords provided by Seoul National University Bundang Hospital:
Coronary atherosclerosis, Spiral Computed Tomography
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases