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

October 7, 2009
March 18, 2013
October 2009
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • Major cardiovascular events (Cardiovascular death, non-fatal MI, heart failure requiring hospitalization, or any stroke) [ 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 ]
Complete list of historical versions of study NCT00991835 on ClinicalTrials.gov Archive Site
  • 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 ]
The impact of statin on the changes in coronary plaque characteristics [ Time Frame: 2 years after CT-scan ] [ Designated as safety issue: No ]
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 ]
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

patients reffered to cardiovascular hospital

  • Atherosclerosis
  • Cardiovascular Diseases
  • Coronary Artery Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3015
December 2014
December 2012   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00991835
PREDICT2009
No
Yasuki Kihara, Hiroshima University
Hiroshima University
Not Provided
Study Chair: Yasuki Kihara, MD,PhD Hiroshima University
Hiroshima University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP