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

August 23, 2018 updated by: Washington University School of Medicine

Comparison of Cardiac Positron Emission Tomography/Computed Tomography (PET/CT) With Coronary Angiography (CA) and Intravascular Ultrasound (IVUS) 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Cardiovascular Imaging Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Positron Emitting Image
Patient will have a PET/CT imaging study to determine cardiac stenosis, F-18 FDG and heparin/intralipid infusion and Contrast Dye.will be administered.
Diagnostic test: PET/CT
Patient will have one imaging modality - a Positron Emitting Tomography CT which includes F-18 FDG and heparin/intralipid infusion and Contrast Dye.
Other Names:
  • PET/positron Emission Tomography imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Clear Anatomical Landmarks Confirmed by CT
Time Frame: During PET CT scan, an average of 2 hours
Coronary FDG uptake will be measured at the site of coronary stenosis. The target coronary stenosis will be identified by its proximity to a clear anatomical landmark seen on CT and conventional angiography.
During PET CT scan, an average of 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Peter Rao, MD, Washington University in St. Louis Physicians

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

February 20, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Actual)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-0813
  • 593F (Other Identifier: RDRC)
  • NCT00850473 (Registry Identifier: PET/CT study in the Diagnosis of Coronary Plaque)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

there is no plan to make individual participant data available to other researchers

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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