We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Plaque Registration and Event Detection In Computed Tomography (PREDICT)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Yasuki Kihara, Hiroshima University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00991835
First Posted: October 8, 2009
Last Update Posted: March 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yasuki Kihara, Hiroshima University
  Purpose
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.

Condition
Atherosclerosis Cardiovascular Diseases Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Yasuki Kihara, Hiroshima University:

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

Secondary Outcome Measures:
  • All coronary events (Cardiac death, non-fatal MI, unstable angina requiring hospitalization, late coronary revascularizations) [ Time Frame: 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 ]

Other Outcome Measures:
  • 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 ]

Enrollment: 3015
Study Start Date: October 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients reffered to cardiovascular hospital
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991835


Locations
Japan
Hiroshima University Graduate School of Biomedical and Health Sciences, Department of Cardiovascular Medicine
Hiroshima, Japan, 734-8551
Sponsors and Collaborators
Hiroshima University
Investigators
Study Chair: Yasuki Kihara, MD,PhD Hiroshima University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yasuki Kihara, Department of Cardiovascular Medicine, Graduate School of Biomedical Sciences, Hiroshima University
ClinicalTrials.gov Identifier: NCT00991835     History of Changes
Other Study ID Numbers: PREDICT2009
First Submitted: October 7, 2009
First Posted: October 8, 2009
Last Update Posted: March 20, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases