Plaque Registration and Event Detection In Computed Tomography (PREDICT)

March 18, 2013 updated by: Yasuki Kihara, Hiroshima University

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

3015

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

  • Japan
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Graduate School of Biomedical and Health Sciences, Department of Cardiovascular Medicine

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients reffered to cardiovascular hospital

Description

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major cardiac events (Cardiac death and acute coronary syndrome)
Time Frame: 2 years after the CT-scan
2 years after the CT-scan
All-cause death
Time Frame: 2 years after the CT-scan
2 years after the CT-scan

Secondary Outcome Measures

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

Other Outcome Measures

Outcome 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
Time Frame: 2 years after CT
2 years after CT

Collaborators and Investigators

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

Sponsor

Hiroshima University

Investigators

  • Study Chair: Yasuki Kihara, MD,PhD, Hiroshima University

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

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

October 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

October 7, 2009

First Submitted That Met QC Criteria

October 7, 2009

First Posted (Estimate)

October 8, 2009

Study Record Updates

Last Update Posted (Estimate)

March 20, 2013

Last Update Submitted That Met QC Criteria

March 18, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREDICT2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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