Plaque Registration and Event Detection In Computed Tomography

• Conditions: Atherosclerosis; Cardiovascular Diseases; Coronary Artery Disease

• Registration Number: NCT00991835
• Lead Sponsor: Hiroshima University

Brief Summary

Disruption of an atherosclerotic plaque is responsible for at least two-thirds of acute coronary syndrome. Thus, identification of plaques vulnerable to rupture has become important. The natural history of individual plaques is unknown and needs to be established. Multidetector computed tomography (MDCT) angiography is a useful noninvasive imaging modality for assessing coronary plaque characteristics. Using MDCT, the researchers prospectively investigate the relationship between the characterization of coronary plaques and cardiovascular events in a large multicenter study.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-07
• Study First Posted: 2009-10-08
• Primary Completion: 2012-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-18
• Last Update Posted: 2013-03-20
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3015

Inclusion Criteria

• patients with known or suspected coronary artery disease.

Exclusion Criteria

• irregular heart beat,
• known allergy towards the contrast agent,
• renal dysfunction,
• uncontrolled heart failure,
• previous coronary bypass surgery, or pacemaker or ICD implantation, ST elevation MI or unstable hemodynamic condition,
• impossible breath-hold, OR
• end-stage cancer.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major cardiac events (Cardiac death and acute coronary syndrome)	2 years after the CT-scan
All-cause death	2 years after the CT-scan

Secondary Outcome Measures

Name	Time	Method
All coronary events (Cardiac death, non-fatal MI, unstable angina requiring hospitalization, late coronary revascularizations)	2 years after CT-scan
All cardiovascular events (Death, acute coronary syndrome, heart failure, cerebral disease, peripheral artery disease, aortic disease, and renal failure)	2 years after the CT-scan

Trial Locations

Locations (1)

Hiroshima University Graduate School of Biomedical and Health Sciences, Department of Cardiovascular Medicine; 🇯🇵 Hiroshima, Japan