An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)
Purpose
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.
Condition
- Coronary Artery Disease (CAD)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental 1 |
Flurpiridaz PET MPI (following off-study SPECT MPI) |
|
More Details
- Status
- Completed
- Sponsor
- GE Healthcare