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CardioPET as PET Imaging Agent to Assess Myocardial Perfusion and Fatty Acid Uptake in Known or Suspected CAD Subjects

Coronary Artery Disease Clinical Trial

Official title:
A Phase II Open-Labeled Study to Evaluate CardioPET™ as a PET Imaging Agent for Evaluation of Myocardial Perfusion and Fatty Acid Uptake in Subjects With Coronary Artery Disease

Clinical Trial Summary

The study is designed to evaluate how safe and how well an investigational imaging product CardioPET™ performs as compared to standard approved imaging products in assessing the function of heart muscle in coronary artery disease patients.

Clinical Trial Description

The open label, phase II, multi center, study objectives are as follows:

- To evaluate the diagnostic performance of CardioPET™ in assessing myocardial perfusion as compared to standard Tc-99m myocardial perfusion agents with coronary angiography as the standard of reference for CAD.

- To evaluate the safety of CardioPET™ in known or suspected CAD subjects.

- A secondary objective is to assess fatty acid uptake at rest and following stress. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01826773
Study type Interventional
Source Fluoropharma, Inc.
Contact
Status Completed
Phase Phase 2
Start date March 2013
Completion date September 2016
View Details
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