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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Seoul National University Bundang Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00431860
First received: February 5, 2007
Last updated: May 2, 2007
Last verified: May 2007
  Purpose

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 Intervention
Coronary Atherosclerosis
Procedure: Coronary computed tomographic angiography

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Longitudinal
Official Title: Subclinical COronary Atheroscleorosis Updated With Coronary cT Angiography (SCOUT Study)

Resource links provided by NLM:


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

Estimated Enrollment: 3000
Study Start Date: December 2005
Estimated Study Completion Date: November 2011
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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431860

Contacts
Contact: Huk-Jae Chang, MD, PhD 82-31-787-7024 hjchang@snu.ac.kr

Locations
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    hjchang@snubh.org   
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Study Director: Huk-Jae Chang, MD, PhD Seoul National University Bundang Hospital
  More Information

No publications provided by Seoul National University Bundang Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00431860     History of Changes
Other Study ID Numbers: B-0606/034-019
Study First Received: February 5, 2007
Last Updated: May 2, 2007
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
Coronary atherosclerosis, Spiral Computed Tomography

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

ClinicalTrials.gov processed this record on September 22, 2014