A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.
Coronary Artery Disease
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary Artery Disease., Positron Emission Tomography Myocardial Perfusion Imaging., Single Positron Emission Computed Tomography., Flurpiridaz F18 Injection.
Eligibility Criteria
Inclusion Criteria:
Invasive Coronary Angiography. Men or Women age 18 or older - see protocol for additional details.
Exclusion Criteria:
Women who are pregnant, lactating, or of child bearing potential who are not practicing birth control.
Unstable cardiac status. History of coronary artery bypass graft. History of percutaneous coronary intervention within the past six months. See protocol for additional details.
Sites / Locations
- Cardiology Associates of Mobile, Inc.
- Scottsdale Medical Imaging, Ltd.
- West Side Medical Associates of Los Angeles
- USC PET Imaging Science Center
- Cedars-Sinai Medical Center
- VA West Los Angeles Medical Center
- UCLA
- Veterans Affairs Palo Alto Health Care System
- Cardiovascular Consultants Medical Group
- Northern California PET Imaging Center-Palo Alto
- VA San Diego Healthcare System
- UCSF Medical Center
- Yale University
- Alfieri Cardiology
- Christiana Care Health System
- Elite Research and Clinical Trials
- Independent Imaging, LLC
- Coastal Cardiology Consultants dba The Heart & Vascular Institute of Florida
- Florida Heart Associates
- St. Luke's Cardiology Associates
- The Cardiovascular Center, PA
- Florida Hospital/Cardiovascular Institute (Florida Heart Group)
- South Florida Research Solutions
- Memorial Hospital of Tampa
- Georgia Health Sciences Univ/Med College of GA
- South Coast Imaging Center
- Gateway Cardiology, PC
- Norton Cardiovascular Associates
- Biomedical Research Foundation of Northwest Louisiana
- Maine Research Associates
- Johns Hopkins University
- Mass General Hospital (MGH)
- Boston University Medical Center
- University of Michigan Health System
- Wayne State University - Harper University Hospital
- Henry Ford Hospital
- St. Mary's Healthcare (Trinity Health)
- McLaren Macomb
- William Beaumont Hospital
- Hattiesburg Clinic
- Missouri Cardiovascular Specialists, LLP
- Cardiovascular Imaging Technologies (CVIT)
- Saint Louis University School of Medicine
- Washington University School of Medicine
- Las Vegas Radiology
- Montefiore Medical Center
- Mount Sinai Medical Center
- Columbia University Medical Center
- St. Francis Hospital
- University of Cincinnati
- The Ohio State University
- OhioHealth Research Institute
- Kettering Medical Center
- Pinnacle Health Cardiovascular Institute/ Associated Cardiologists
- Allegheny General Hospital
- Presbyterian University Hospital
- Berks Cardiologists, Ltd.
- York Hospital /Wellspan Health
- Rhode Island Hospital
- Medical University of South Carolina
- Wellmont CVA Heart Institute
- Center for Biomedical Research
- Cardiovascular Research of Knoxville - St. Mary's Health Care System, Inc.
- Vanderbilt Heart and Vascular Institute
- Dallas VA Medical Center
- University of Texas Medical Branch
- Excel Diagnostics and Nuclear Oncology Center
- Katy Cardiology
- West Houston Area Clinical Trial Consultants, LLC
- University of Virginia Health System
- McGuire Veteran Affairs Medical Center
- Carilion Cardiology Clinic
- Roanoke Heart Institute
- University of Western Ontario
- KMH Cardiology and Diagnostic and MRI Centres
- University of Ottawa Heart Institute
- Centre Hospitalier Universitaire de Sherbrooke (CHUS)
- Helsinki University Hospital
- Turku PET Centre
- San Patricio MEDFLIX (San Patricio MRI & CT Center)
- VA Caribbean Healthcare System
Arms of the Study
Arm 1
Experimental
Flurpiridaz F18
Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to a single dose of 99mTc sestamibi or tetrofosmin for SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization