Condition: Coronary artery disease
Key Inclusion Criteria:
- At least 18 years old
- Scheduled to undergo an invasive coronary angiography for the assessment of coronary artery disease at the time of enrollment
- Signed consent form and willing to allow researchers to make medical records available to GE Healthcare
Key Exclusion Criteria:
- Pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating
- Unable to undergo all imaging procedures
- Has unstable cardiovascular condition
A Phase III, Open-Label, Multicenter Study of Flurpiridaz (F-18) Injection for Postiron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease (IRB no. 52710)
This study focuses on patients who are scheduled to have an invasive coronary angiography (cardiac catheterization) as part of their standard of care. The purpose of the study is to evaluate how well an investigational imaging drug called flurpiridaz (F-18) can detect coronary artery disease. Coronary artery disease is a condition that decreases blood flow to the heart.
Flurpiridaz contains a very small dose of radioactivity that is given through an intravenous catheter. As soon as it is injected, a positron emission tomography (PET) camera will be used to take pictures of the blood flow to the heart muscles. Researchers will compare pictures of the heart taken from a standard camera called single photon emission computed tomography (SPECT) with the pictures taken using the PET camera after the injection of flurpiridaz. The PET images will also be compared to the results of the patient’s cardiac catheterization. These comparisons will help researchers assess how accurately flurpiridaz injection PET imaging can detect coronary artery disease. The study will also collect information to evaluate the safety of flurpiridaz.
Financial disclosure: The principal investigator, Daniel Berman, MD, receives payment from the company sponsoring the study as a member of the Scientific Advisory Committee for this protocol. The principal investigator and institution have no other potential financial conflict of interest.