Phase 3
Completed N=795
A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.
Source: ClinicalTrials.gov NCT01347710 ↗Enrolled (actual)
795
Serious AEs
2.5%
Results posted
Apr 2016
Primary outcomePrimary: Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity — .719; .537 Proportion of true positive cases — p=<0.001
◆ Published Evidence
Highly cited
141citations · ~24 / year
Phase-III Clinical Trial of Fluorine-18 Flurpiridaz Positron Emission Tomography for Evaluation of Coronary Artery Disease.
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).
Linked Publications (4)
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Phase-III Clinical Trial of Fluorine-18 Flurpiridaz Positron Emission Tomography for Evaluation of Coronary Artery Disease.
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Multi-center, multi-vendor validation of deep learning-based attenuation correction in SPECT MPI: data from the international flurpiridaz-301 trial.
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Integrated myocardial flow reserve (iMFR) assessment: optimized PET blood flow quantification for diagnosis of coronary artery disease.
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Utility of <sup>18</sup>F-Flurpiridaz PET Relative Flow Reserve in Differentiating Obstructive From Nonobstructive Coronary Artery Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity |
.719; .537 | <0.001 sig |
| PRIMARY Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity |
.762; .868 | .945 |
| SECONDARY Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. |
0.736; 0.533; 0.644; 0.356; 0.722; 0.533 | <0.001 sig |
| SECONDARY Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. |
.773; .875; .795; .869; .777; .850 | 0.891 |
| SECONDARY Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT). |
.495; .333; .398; .251; .596; .476 | <0.001 sig |
| SECONDARY Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT). |
.867; .932; .904; .970; .845; .912 | .379 |
| SECONDARY Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT). |
.882; .964 | 0.827 |
| SECONDARY Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good |
.711; .539 | <0.001 sig |
| SECONDARY Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good |
.769; .880 | 0.954 |
| SECONDARY Image Quality of Rest and Stress (PET vs SPECT). |
.891; .739; .976; .869; .109; .261 | <0.001 sig |
| SECONDARY Diagnostic Certainty in PET MPI and SPECT MPI |
0.862; 0.138; 0.799; 0.201 | <0.001 sig |
Eligibility Criteria
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 percutaneous coronary intervention within the past six months. See protocol for additional details.
Data sourced from ClinicalTrials.gov (NCT01347710) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.