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Subclinical COronary Atheroscleorosis Updated With Coronary cT Angiography (SCOUT Study)
This study is currently recruiting participants.
Study NCT00431860   Information provided by Seoul National University Bundang Hospital
First Received: February 5, 2007   Last Updated: May 2, 2007   History of Changes

February 5, 2007
May 2, 2007
December 2005
 
 
 
Complete list of historical versions of study NCT00431860 on ClinicalTrials.gov Archive Site
 
 
 
Subclinical COronary Atheroscleorosis Updated With Coronary cT Angiography (SCOUT Study)
Subclinical COronary Atheroscleorosis Updated With Coronary cT Angiography (SCOUT Study)

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

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.

 
Observational
Natural History, Longitudinal, Case Control, Retrospective/Prospective Study
Coronary Atherosclerosis
Procedure: Coronary computed tomographic angiography
 
Choi EK, Choi SI, Rivera JJ, Nasir K, Chang SA, Chun EJ, Kim HK, Choi DJ, Blumenthal RS, Chang HJ. Coronary computed tomography angiography as a screening tool for the detection of occult coronary artery disease in asymptomatic individuals. J Am Coll Cardiol. 2008 Jul 29;52(5):357-65.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
3000
November 2011
 

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)
Both
20 Years to 75 Years
No
Contact: Huk-Jae Chang, MD, PhD 82-31-787-7024 hjchang@snu.ac.kr
Korea, Republic of
 
NCT00431860
 
B-0606/034-019
Seoul National University Bundang Hospital
 
Study Director: Huk-Jae Chang, MD, PhD Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP