An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)
Condition: Coronary Artery Disease (CAD)
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: PET MPI; SPECT MPI; Pharmacological stress agents
Intervention description: Flurpiridaz (18F) Injection. All participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein: 1 at rest and 1 during stress. The dosages of Flurpiridaz (18F) Injection administered at rest and during stress conditions did not exceed a total of 14 mCi (520 MBq) for an individual participant.; SPECT imaging was used 99mTc-based myocardial tracers. SPECT agents utilised for the purposes of this clinical study was administered as per American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards, where applicable. All participants undergone SPECT MPI.; Pharmacologic stress agents were restricted to the following 3 agents, as permitted by local marketing authorisations and availability: adenosine, dipyridamole, and regadenoson. Administration was through an IV line.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 730.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Positron emission tomography myocardial perfusion imaging (PET MPI); Single photon emission computed tomography myocardial perfusion imaging (SPECT MPI); Invasive coronary angiography (ICA); Coronary artery disease (CAD)

Summary:

      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.
    

Eligibility criteria:

        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.