An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)

A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred for Invasive Coronary Angiography Because of Suspected Coronary Artery Disease

This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.

Inclusion Criteria:

• The participant was a man or woman ≥18 years of age.
• The participant had read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed.
• At the time of enrolment, the participant had been scheduled via written documentation to undergo an ICA for the assessment of CAD.
• The participant had undergone a clinically indicated SPECT OR the participant was willing to undergo SPECT MPI for the purposes of the clinical study.
• The participant was male or was a nonpregnant, nonlactating female who was either surgically sterile or was post-menopausal.
• The participant was able and willing to comply with all study procedures as described in the protocol.

Exclusion Criteria:

• Participants who were pregnant, may possibly be pregnant, or wish (including their partners) to became pregnant during the study period, or were lactating.

• Participants who were unable to undergo all of the imaging procedures.

• Participants who had an established diagnosis of CAD as confirmed by any of the following:

  1. Previous myocardial infarction (MI);
  2. Previous cardiac catheter angiography showing ≥50% stenosis;
  3. Previous coronary revascularisation, such as percutaneous coronary intervention (PCI), thrombolysis or coronary artery bypass graft (CABG) placement.

• Participants incapable of undergoing either exercise or pharmacological cardiac stress testing.

• Participants who had a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the participant during cardiac stress testing.

• Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) <50%).

• Participants scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ICA.

• Participants undergoing evaluation for heart transplantation or with history of heart transplantation.

• Participants enrolled in another clinical study within the 30 days prior to being enrolled in this study or scheduled to participate in another clinical study during the 7-day follow-up period of this study.