Status:
COMPLETED
An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)
Lead Sponsor:
GE Healthcare
Collaborating Sponsors:
Pharmaceutical Product Development, (PPD) LLC
Conditions:
Coronary Artery Disease (CAD)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
- 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
- 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:
- 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.
- 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.
Key Trial Info
Start Date :
June 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2022
Estimated Enrollment :
730 Patients enrolled
Trial Details
Trial ID
NCT03354273
Start Date
June 5 2018
End Date
May 5 2022
Last Update
July 12 2023
Active Locations (53)
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1
Vascular Biology and Hypertension Program, University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of California- Los Angeles
Los Angeles, California, United States, 90024
3
Keck Hospital of USC
Los Angeles, California, United States, 90033
4
VA Greater Los Angeles Health Care System
Los Angeles, California, United States, 90073