A Phase 3, Open Label, Multicenter Study for the Assessment of Myocardial Perfusion Using Positron Emission Tomography (PET) Imaging of Flurpiridaz F18 Injection in Patients With Suspected or Known Coronary Artery Disease (CAD)
A Phase 3, Open Label, Multicenter Study for the Assessment of Myocardial Perfusion Using Positron Emission Tomography (PET) Imaging of Flurpiridaz F18 Injection in Patients With Suspected or Known Coronary Artery Disease (CAD)
The study will evaluate the use of Flurpiridaz F18 injection in patients with CAD to determine if the study drug in PET imaging is better than SPECT imaging currently used for this purpose.
The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz F18 Injection MPI in comparison with SPECT MPI in patients with known or suspected CAD. Six hundred and seventy-two evaluable patients will be enrolled and will undergo SPECT MPI and Flurpiridaz F18 PET MPI. Patients will be considered for enrollment if they are scheduled to undergo or have undergone prior ICA without intervention (being either positive or negative for CAD).
Inclusion Criteria:
Invasive Coronary Angiography Men or Women age 18 or older - see protocol for additional details
Exclusion Criteria:
Women who are pregnant, lactating, or of child bearing potential who are not practicing birth control Unstable cardiac status History of coronary artery bypass graft History of PCI within the past six months See protocol for additional details