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PET/CT Study in the Diagnosis of Coronary Plaque

This study has been completed.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00850473
First received: February 20, 2009
Last updated: May 11, 2011
Last verified: May 2011
History of Changes

February 20, 2009
May 11, 2011
October 2007
September 2009   (final data collection date for primary outcome measure)
To determine if a combined non-invasive cardiac imaging test (PET/CT) can determine coronary plaque severity, morphology and metabolic activity when compared to the gold standard of coronary angiography and intravascular ultrasound. [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00850473 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
PET/CT Study in the Diagnosis of Coronary Plaque
x Comparison of Cardiac Positron Emission Tomography/Computed Tomography (PET/CT) With Coronary Angiography (CA) in the Diagnosis and Characterization of Coronary Artery Plaque

This study is being done to determine if a picture taking test of the heart, positron emission tomography/computed tomography (or cardiac PET/CT), can identify the blockages in the heart arteries that lead to heart attacks when compared to the standard of heart catheterization.

Heart catheterization, in which a thin plastic tube, or catheter, is placed into an artery in the arm or leg and advanced into the heart arteries, is the procedure that you and your doctor have decided to pursue to look for heart artery blockages. It is being performed as part of your standard care and not for research purposes. The research procedure (cardiac PET/CT), which will be performed at a later date is a combination of heart CT (a test that involves the use of x-rays to identify heart artery blockages) and heart PET (an imaging test that uses a radioactive drug to look at how the heart uses fuel (sugar and fats) These tests will be combined (PET/CT) to look for the presence and type of blockage in your heart arteries.

It is important to develop a test that can determine if and what type of blockage you have in your heart arteries as the presence and type of heart artery blockage is a very important predictor of heart attack and death from heart attack.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Myocardial Infarction
  • Coronary Artery Disease
  • Cardiac Catheterization
  • Radiation: Positron Emission Tomography
    image scan. approximately 1 hour
    Other Name: PET
  • Radiation: 18F- FDG
    maximum of 10mCi of 18F-FDG will be injected for imaging purposes
  • Radiation: Computed Tomography
    image scan
    Other Name: CT.
  • Drug: CT Contrast Dye
    used for obtaining images. weight based dose
    Other Name: CT contrast
Experimental: PET/CT
If enrolled in this study, the participant will have a PET/CT along with their Cardiac Catheterization to compare usability of images in diagnosis of heart vessel disease.
Interventions:
  • Radiation: Positron Emission Tomography
  • Radiation: 18F- FDG
  • Radiation: Computed Tomography
  • Drug: CT Contrast Dye
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years oof age or older
  • referred for cardiac catheterization.
  • coronary artery disease that does not need angioplasty.

Exclusion Criteria:

  • history of cardiac stents
  • bypass surgery
  • bad kidney function
  • unable to take beta blocker medication
  • history of asthma
  • allergies to egg containing products
  • atrial fibrillation
  • pregnancy
  • breastfeeding
  • overweight by definition of a BMI over 35.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00850473
07-0813, 593F
Yes
Peter Rao, MD, Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Peter Rao, MD Washington University in ST Louis Physicians
Washington University School of Medicine
May 2011

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