Plaque Registration and Event Detection In Computed Tomography

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00991835

Acronym

PREDICT

Enrollment

3015

Registered

2009-10-08

Start date

2009-10-31

Completion date

2014-12-31

Last updated

2013-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Cardiovascular Diseases, Coronary Artery Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Other

Measure	Time frame
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

Countries

Japan

Outcome results