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PET/CT Study in the Diagnosis of Coronary Plaque (PET/CT)

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ClinicalTrials.gov Identifier: NCT00850473
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : May 5, 2014
Sponsor:
Information provided by (Responsible Party):
Robert Gropler, Washington University School of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Myocardial Infarction Coronary Artery Disease Cardiac Catheterization Radiation: Positron Emission Tomography Radiation: 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose Radiation: Computed Tomography Drug: CT Contrast Dye Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : October 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
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.
Radiation: Positron Emission Tomography
image scan. approximately 1 hour
Other Name: PET
Radiation: 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose
maximum of 10mCi of 18F-FDG will be injected for imaging purposes
Other Name: 18F- FDG
Radiation: Computed Tomography
image scan
Other Name: CT.
Drug: CT Contrast Dye
used for obtaining images. weight based dose
Other Name: CT contrast



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): NCT00850473


Locations
United States, Missouri
Cardiovascular Imaging Laboratory
St Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Peter Rao, MD Washington University in St. Louis Physicians

Responsible Party: Robert Gropler, Professor of Radiology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00850473     History of Changes
Other Study ID Numbers: 07-0813
593F
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: May 5, 2014
Last Verified: May 2014

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

Additional relevant MeSH terms:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Fluorodeoxyglucose F18
Deoxyglucose
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antiviral Agents
Anti-Infective Agents