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Plaque Registration and Event Detection In Computed Tomography (PREDICT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yasuki Kihara, Hiroshima University
ClinicalTrials.gov Identifier:
NCT00991835
First received: October 7, 2009
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Hiroshima University:

Primary Outcome Measures:
  • Major cardiac events (Cardiac death and acute coronary syndrome) [ Time Frame: 2 years after the CT-scan ] [ Designated as safety issue: No ]
  • All-cause death [ Time Frame: 2 years after the CT-scan ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 7, 2009
Last Updated: March 18, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on May 19, 2013