Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease. Positron Emission Tomography Myocardial Perfusion Imaging. Single Positron Emission Computed Tomography. Flurpiridaz F18 Injection.
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 795
Healthy volunteers: no

Brief summary:
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).

Detailed description:
The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz F18 Injection MPI against SPECT MPI in patients screened for CAD as determined by ICA. Six hundred and eighty evaluable patients will be enrolled and will undergo SPECT MPI and Flurpiridaz F18 PET MPI. Patients will be considered for enrollment if they are scheduled to undergo or have undergone prior ICA without intervention (being either positive or negative for CAD).

Arms:
arm 1: 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

Interventions: intervention 1: Flurpiridaz F18 intervention 2: 99mTechnicium (sestamibi or tetrofosmin)
Intervention descriptions: intervention 1: Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis intervention 2: Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis

Protocol document: