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PET/CT Study in the Diagnosis of Coronary Plaque
This study is currently recruiting participants.
Verified by Washington University School of Medicine, February 2009
First Received: February 20, 2009   Last Updated: February 24, 2009   History of Changes
Sponsored by: Washington University School of Medicine
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00850473
  Purpose

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.


Condition Intervention
Myocardial Infarction
Coronary Artery Disease
Cardiac Catheterization
Radiation: Positron Emmission Tomography
Radiation: 18F- FDG
Radiation: Computed Tomography
Drug: CT Contrast Dye

Study Type: Interventional
Study Design: Diagnostic, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: x Comparison of Cardiac Positron Emission Tomography/Computed Tomography (PET/CT) With Coronary Angiography (CA) in the Diagnosis and Characterization of Coronary Artery Plaque

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: October 2007
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PET/CT: Experimental
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.
Radiation: Positron Emmission Tomography
image scan. approximately 1 hour
Radiation: 18F- FDG
maximum of 10mCi of 18F-FDG will be injected for imaging purposes
Radiation: Computed Tomography
image scan
Drug: CT Contrast Dye
used for obtaining images. weight based dose

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00850473

Contacts
Contact: Kitty Krupp, RN 314-747-0183 kruppk@mir.wustl.edu
Contact: Debi Delano, MSN 314-747-3876 delanod@mir.wustl.edu

Locations
United States, Missouri
Cardiovascular Imaging Laboratory Recruiting
St Louis, Missouri, United States, 63110
Contact: Kitty Krupp, RN     314-747-0183     kruppk@mir.wustl.edu    
Principal Investigator: Peter Rao, MD            
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Peter Rao, MD Washington University in ST Louis Physicians
  More Information

No publications provided

Responsible Party: Washington University School of Medicine ( Peter Rao, MD )
Study ID Numbers: 07-0813, 593F
Study First Received: February 20, 2009
Last Updated: February 24, 2009
ClinicalTrials.gov Identifier: NCT00850473     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
PET
CT
Heart Attack
Coronary Artery disease
Cardiac Catheterization

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Infarction
Myocardial Infarction
Coronary Artery Disease

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Disease
Necrosis
Pathologic Processes
Cardiovascular Diseases
Infarction
Myocardial Infarction
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 10, 2009