Open Actively Recruiting
An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)
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.
- The subject is a man or woman ≥18 years of age.
- The subject has read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed.
- At the time of enrolment, the subject has been scheduled via written documentation to undergo an ICA for the assessment of CAD.
- The subject has undergone a clinically indicated SPECT OR the patient is willing to undergo SPECT MPI for the purposes of the clinical study.
- The subject is male or is a nonpregnant, nonlactating female who is either surgically sterile or is post-menopausal.
- The subject is able and willing to comply with all study procedures as described in the protocol.
- Patients who are pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating.
- Patients who are unable to undergo all of the imaging procedures.
- Patients who have an established diagnosis of CAD as confirmed by any of the
- Previous myocardial infarction (MI);
- Previous cardiac catheter angiography showing ≥50% stenosis;
- Previous coronary revascularisation, such as percutaneous coronary intervention (PCI), thrombolysis or coronary artery bypass graft (CABG) placement.
- Patients incapable of undergoing either exercise or pharmacological cardiac stress testing.
- Patients who have a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the patient during cardiac stress testing.
- Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) <50%).
- Patients scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ICA.
- Patients undergoing evaluation for heart transplantation or with history of heart transplantation.
- Patients 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.
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