Subclinical COronary Atheroscleorosis Updated With Coronary cT Angiography (SCOUT Study)
NCT ID: NCT00431860
Last Updated: 2007-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
3000 participants
OBSERVATIONAL
2005-12-31
2011-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
OTHER
Interventions
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Coronary computed tomographic angiography
Eligibility Criteria
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Inclusion Criteria
* 20-75 years
* subjects who had undergone spiral coronary CT angiography for health check-up
Exclusion Criteria
* serious comorbid conditions(i.e. malignancy)
20 Years
75 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Principal Investigators
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Huk-Jae Chang, MD, PhD
Role: STUDY_DIRECTOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang hospital
Sungnam-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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. doi: 10.1016/j.jacc.2008.02.086.
Other Identifiers
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B-0606/034-019
Identifier Type: -
Identifier Source: org_study_id