The study will evaluate the use of Flurpiridaz F18 injection in patients with CAD to determine if the study drug in PET imaging is better than SPECT imaging currently used for this purpose.
The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz F18 Injection MPI in comparison with SPECT MPI in patients with known or suspected CAD. Six hundred and seventy-two 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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography
Time frame: 12 months
Diagnostic performance evaluation of CAD (PETVsSPECT)
Time frame: 12 months
Diagnositic performance evaluation of multivessel disease (PETvsSPECT)
Time frame: 12 months
Detection of CAD in subgroups: pharm stress, females and BMI>/=30
Time frame: 12 months
Image quality of rest and stress (PETvsSPECT)
Time frame: 12 months
Diagnostic certainty evaluation of rest and stress (PETvsSPECT)
Time frame: 12 months
Evaluation of reversible defect size of rest and stress (PETvsSPECT)
Time frame: 12 months
Safety evaluation of flurpiridaz F 18 will include monitoring the number participants with adverse events (AEs), medication errors, treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs).
Time frame: 12 months
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