A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.

Completed · Phase 3

Conditions studied: Coronary Artery Disease

In brief

The primary objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to single photon emission computed tomography (SPECT) MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a documented history of Myocardial Infarction (MI).

Key facts

Study ID

NCT01347710

Run by

Lantheus Medical Imaging

People needed

795

Starts

2011-06-01

Expected to finish

2013-09-01

Last updated by the study team

2020-11-24

Who can join

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

You may qualify if…

• Invasive Coronary Angiography. Men or Women age 18 or older - see protocol for additional details.

You may not qualify if…

• 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.

Where it is running

• Scottsdale Medical Imaging, Ltd. — Scottsdale, Arizona, United States
• West Side Medical Associates of Los Angeles — Beverly Hills, California, United States
• USC PET Imaging Science Center — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• VA West Los Angeles Medical Center — Los Angeles, California, United States
• UCLA — Los Angeles, California, United States
• Veterans Affairs Palo Alto Health Care System — Palo Alto, California, United States
• Cardiovascular Consultants Medical Group — Pleasant Hill, California, United States
• Northern California PET Imaging Center-Palo Alto — Sacramento, California, United States
• VA San Diego Healthcare System — San Diego, California, United States
• UCSF Medical Center — San Francisco, California, United States
• Yale University — New Haven, Connecticut, United States
• Alfieri Cardiology — Newark, Delaware, United States
• Christiana Care Health System — Newark, Delaware, United States
• Elite Research and Clinical Trials — Aventura, Florida, United States
• Independent Imaging, LLC — Boynton Beach, Florida, United States
• Coastal Cardiology Consultants dba The Heart & Vascular Institute of Florida — Clearwater, Florida, United States
• Florida Heart Associates — Fort Myers, Florida, United States
• St. Luke's Cardiology Associates — Jacksonville, Florida, United States
• The Cardiovascular Center, PA — Lake Mary, Florida, United States
• Florida Hospital/Cardiovascular Institute (Florida Heart Group) — Orlando, Florida, United States
• South Florida Research Solutions — Pembroke Pines, Florida, United States
• Memorial Hospital of Tampa — Tampa, Florida, United States
• Georgia Health Sciences Univ/Med College of GA — Augusta, Georgia, United States
• Cardiology Associates of Mobile, Inc. — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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