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

Completed · Phase 3

Conditions studied: Coronary Artery Disease (CAD)

In brief

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.

Key facts

Study ID

NCT03354273

Run by

GE Healthcare

People needed

730

Starts

2018-06-05

Expected to finish

2022-05-05

Last updated by the study team

2023-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California- Los Angeles — Los Angeles, California, United States
• Keck Hospital of USC — Los Angeles, California, United States
• VA Greater Los Angeles Health Care System — Los Angeles, California, United States
• VA San Diego Health System — San Diego, California, United States
• UCSF — San Francisco, California, United States
• Tower Saint John's Imaging — Santa Monica, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Cardiology Physicians PA/Red Clay Research LLC — Newark, Delaware, United States
• University of Florida — Gainesville, Florida, United States
• Indago Research and Health Center — Hialeah, Florida, United States
• Optimus U Corp — Miami, Florida, United States
• Infinite Clinical Research — Miami, Florida, United States
• Allied Biomedical Research Institute — Miami, Florida, United States
• Comprehensive Vascular Care PA — Miami, Florida, United States
• Amavita Clinical Research, LLC — North Miami Beach, Florida, United States
• Emory University — Atlanta, Georgia, United States
• University Of Iowa Hospitals And Clinics — Iowa City, Iowa, United States
• Midwest Heart and Vascular Specialists — Overland Park, Kansas, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• VA St. Louis Health Care System — St Louis, Missouri, United States
• St Louis University — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Columbia University Medical Center/New York Presbyterian Hospital - Milstein Hospital Building — New York, New York, United States
• Vascular Biology and Hypertension Program, University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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