PET/CT Study in the Diagnosis of Coronary Plaque

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Gropler, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00850473
First received: February 20, 2009
Last updated: May 2, 2014
Last verified: May 2014
  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 Emission Tomography
Radiation: 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose
Radiation: Computed Tomography
Drug: CT Contrast Dye

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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 ]

Enrollment: 3
Study Start Date: October 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: February 20, 2009
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 20, 2014