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A Phase 3, Open Label, Multicenter Study for the Assessment of Myocardial Perfusion Using Positron Emission Tomography (PET) Imaging of Flurpiridaz F18 Injection in Patients With Suspected or Known Co

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Trial Conditions
  • Coronary Artery Disease
What is the purpose of this trial?

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).

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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 PCI within
the past six months. See protocol for additional details.

Gender: Both
Steward Physician(s)
  • Cesare Orlandi, MD
Trial Interventions
Drug
  • Flurpiridaz F18
Physician Researcher

Investigator Name:

  • Cesare Orlandi, MD

Other Information

Sponsor: Lantheus Medical Imaging
Phase: Phase 3
Trial ID: NCT01347710
Volunteers:  Not Accepting Healthy Volunteers

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