Coronary computed tomographic angiography in Coronary Atherosclerosis - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Coronary Atherosclerosis

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- Kyungki-do
  - Sungnam-si, Kyungki-do, Korea, Republic of
    - Recruiting
    - Seoul National University Bundang Hospital
    - Contact:
      
      Huk-Jae Chang, MD, PhD
      
      Phone Number: 82-32-787-7024
      
      Email: hjchang@snubh.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

Study Director: Huk-Jae Chang, MD, PhD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion (Anticipated)

November 1, 2011

Study Registration Dates

First Submitted

February 5, 2007

First Submitted That Met QC Criteria