Phase 3
Completed N=730
An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)
Source: ClinicalTrials.gov NCT03354273 ↗Enrolled (actual)
730
Serious AEs
3.3%
Results posted
Jul 2023
Primary outcomePrimary: Sensitivity and Specificity of Flurpiridaz (18F) Injection Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) in the Detection of Significant Coronary Artery Disease (CAD) as Defined by Cardiac Catheterization — 77.1; 65.7; 73.5; 69.6 percent — p=<0.0001
◆ Published Evidence
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Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients With Suspected Coronary Artery Disease.
Summary
This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.
Linked Publications (3)
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Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients With Suspected Coronary Artery Disease.
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Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging.
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Improved assessment of coronary artery disease in obese Patients with flurpiridaz-<sup>18</sup>F positron emission tomography myocardial perfusion imaging: A prespecified subgroup analysis of the AURORA phase 3 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity of Flurpiridaz (18F) Injection Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) in the Detection of Significant Coronary Artery Disease (CAD) as Defined by Cardiac Catheterization |
77.1; 65.7; 73.5; 69.6; 88.8; 52.6 | <0.0001 sig |
| SECONDARY Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for All Participants When the Diagnosis of CAD by ICA Was the Standard of Truth |
77.1; 62.7; 65.7; 63.2; 73.5; 60.6 | <0.0001 sig |
| SECONDARY Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Female Participants When the Diagnosis of CAD by ICA Was the Standard of Truth |
82.9; 58.5; 72.8; 63.3; 78.0; 56.1 | 0.0127 sig |
| SECONDARY Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Participants With Body-mass Index (BMI) >=30 Kilograms Per Square Meter (kg/m^2) When the Diagnosis of CAD by ICA Was the Standard of Truth |
72.6; 60.7; 68.0; 61.3; 70.1; 63.2 | 0.0116 sig |
| SECONDARY Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Diabetic Participants When the Diagnosis of CAD by ICA Was the Standard of Truth |
72.5; 61.5; 60.2; 56.3; 69.2; 62.6 | 0.0294 sig |
Eligibility Criteria
Inclusion Criteria
- The participant was a man or woman ≥18 years of age.
- The participant had read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed.
- At the time of enrolment, the participant had been scheduled via written documentation to undergo an ICA for the assessment of CAD.
- The participant had undergone a clinically indicated SPECT OR the participant was willing to undergo SPECT MPI for the purposes of the clinical study.
- The participant was male or was a nonpregnant, nonlactating female who was either surgically sterile or was post-menopausal.
- The participant was able and willing to comply with all study procedures as described in the protocol.
Exclusion Criteria
- Participants who were pregnant, may possibly be pregnant, or wish (including their partners) to became pregnant during the study period, or were lactating.
- Participants who were unable to undergo all of the imaging procedures.
- Participants who had an established diagnosis of CAD as confirmed by any of the following:
- Previous myocardial infarction (MI);
- Previous cardiac catheter angiography showing ≥50% stenosis;
- Previous coronary revascularisation, such as percutaneous coronary intervention (PCI), thrombolysis or coronary artery bypass graft (CABG) placement.
- Participants incapable of undergoing either exercise or pharmacological cardiac stress testing.
- Participants who had a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the participant during cardiac stress testing.
- Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) <50%).
- Participants scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ICA.
- Participants undergoing evaluation for heart transplantation or with history of heart transplantation.
- Participants enrolled in another clinical study within the 30 days prior to being enrolled in this study or scheduled to participate in another clinical study during the 7-day follow-up period of this study.
Data sourced from ClinicalTrials.gov (NCT03354273) 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.