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

Primary Purpose

Myocardial Infarction, Coronary Artery Disease, Cardiac Catheterization

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET/CT
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Infarction focused on measuring PET, CT, Heart Attack, Coronary Artery disease, Cardiac Catheterization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cardiovascular Imaging Laboratory

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Positron Emitting Image

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants With Clear Anatomical Landmarks Confirmed by CT
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.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2009
Last Updated
August 23, 2018
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00850473
Brief Title
PET/CT Study in the Diagnosis of Coronary Plaque
Acronym
PET/CT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Sub-investigator left the university
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Coronary Artery Disease, Cardiac Catheterization
Keywords
PET, CT, Heart Attack, Coronary Artery disease, Cardiac Catheterization

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positron Emitting Image
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/CT
Other Intervention Name(s)
PET/positron Emission Tomography imaging
Intervention Description
Patient will have one imaging modality - a Positron Emitting Tomography CT which includes F-18 FDG and heparin/intralipid infusion and Contrast Dye.
Primary Outcome Measure Information:
Title
Number of Participants With Clear Anatomical Landmarks Confirmed by CT
Description
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.
Time Frame
During PET CT scan, an average of 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Rao, MD
Organizational Affiliation
Washington University in St. Louis Physicians
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Imaging Laboratory
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
there is no plan to make individual participant data available to other researchers

Learn more about this trial

PET/CT Study in the Diagnosis of Coronary Plaque

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