Plaque Registration and Event Detection In Computed Tomography

Coronary Artery Disease Clinical Trial

— PREDICT  

Official title:

Prospective Multicenter Study to Investigate the Relationship Between the Characteristics of Coronary Artery Plaques and Cardiovascular Events Using Multidetector Computed Tomography Coronary Angiography

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00991835
• Other study ID #: PREDICT2009
• Status: Unknown status
• Phase: N/A
• First received: October 7, 2009
• Last updated: March 18, 2013
• Start date: October 2009
• Est. completion date: December 2014

Study information

• Verified date: March 2013
• Source: Hiroshima University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 3015
• Est. completion date: December 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Japan	Hiroshima University Graduate School of Biomedical and Health Sciences, Department of Cardiovascular Medicine	Hiroshima

Sponsors (1)

Lead Sponsor	Collaborator
Hiroshima University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Coronary plaque progression and managements for serum cholesterol, blood glucose, renal function and blood pressure: Especially impacts of statin on the changes in coronary plaque characteristics		2 years after CT
Primary	Major cardiac events (Cardiac death and acute coronary syndrome)		2 years after the CT-scan
Primary	All-cause death		2 years after the CT-scan
Secondary	All coronary events (Cardiac death, non-fatal MI, unstable angina requiring hospitalization, late coronary revascularizations)		2 years after CT-scan
Secondary	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