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delayed study start
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flurpiridaz F18 | Experimental | Open-label study of a single injection of flurpiridaz F18 for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary cathertization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flurpiridaz F18 | Drug | Injection of Flurpiridaz F18 for the purposes of PET MPI analysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance evaluation of CAD (PETVsSPECT) | 12 months | |
| Diagnositic performance evaluation of multivessel disease (PETvsSPECT) | 12 months | |
| Detection of CAD in subgroups: pharm stress, females and BMI>/=30 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Cesare Orlandi, MD | Lantheus Medical Imaging | Study Director |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
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| ID | Term |
|---|---|
| C525920 | BMS 747158-02 |
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| 12 months |
| Image quality of rest and stress (PETvsSPECT) | 12 months |
| Diagnostic certainty evaluation of rest and stress (PETvsSPECT) | 12 months |
| Evaluation of reversible defect size of rest and stress (PETvsSPECT) | 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). | 12 months |