PET/CT Study in the Diagnosis of Coronary Plaque

Not Applicable

Terminated

• Conditions: Myocardial Infarction; Cardiac Catheterization; Coronary Artery Disease
• Interventions: Diagnostic Test: PET/CT

• Registration Number: NCT00850473
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-10
• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-24
• Study First Posted: 2009-02-25
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2018-02-06
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-23
• Last Update Submitted: 2018-08-23
• Results First Posted: 2018-08-29
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Positron Emitting Image	PET/CT	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clear Anatomical Landmarks Confirmed by CT	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.

Trial Locations

Locations (1)

Cardiovascular Imaging Laboratory; 🇺🇸 Saint Louis, Missouri, United States