Clinical trial NCT00431860: Subclinical COronary Atheroscleorosis Updated With Coronary cT Angiography (SCOUT Study)
Official title: Subclinical COronary Atheroscleorosis Updated With Coronary cT Angiography (SCOUT Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Atherosclerosis
Keywords: Coronary atherosclerosis, Spiral Computed Tomography
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2007-02-06
Enrollment: 3000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER

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.

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.

Eligibility criteria: 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sungnam-si
country: Korea, Republic of
facility: Seoul National University Bundang hospital
state: Kyungki-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Huk-Jae Chang, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.