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

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GE Healthcare
• Collaborator: Pharmaceutical Product Development, LLC

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 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.

• 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.