Coronary Artery Disease, Coronary Microvascular Disease
Conditions
Keywords
Myocardial Perfusion Imaging, Nuclear Cardiology, Positron Emission Tomography, Cardiac CT
Brief summary
This study seeks to evaluate if the diagnostic performance of 18F-flurpiridaz positron emission tomography (PET) myocardial perfusion imaging (MPI), given the radiotracer's properties, is non-inferior to the currently most widely utilized PET MPI radiopharmaceutical, 82Rb-chloride.
Detailed description
* Patients will undergo a clinically indicated rest/stress 82Rb-chloride positron emission tomography (PET) myocardial perfusion imaging (MPI) and will return to the nuclear cardiology laboratory within 1-30 days to undergo a 18F-flurpiridaz PET MPI and coronary CT angiogram. A rest 18F-flurpiridaz PET MPI will be acquired first, followed by a stress 18F-flurpiridaz PET MPI. The waiting period between the rest and stress 18F-flurpiridaz PET acquisitions will be ≥ 30 minutes. The rest dose will be 2.5-3.0 mCi, and the pharmacological stress dose will be 6.0-6.5 mCi. All PET MPI studies will be conducted using regadenoson as the pharmacologic stress agent. * 18F-flurpiridaz and 82Rb-chloride PET MPI scans will be interpreted by three expert visual readers in a blinded manner. Both Image quality and diagnostic certainty will be classified using a five-point scale. If the study is abnormal, the perfusion defect will further be categorized as reversible or fixed. Relative perfusion and myocardial blood flow quantification will be obtained using validated software methods. * Coronary CT angiograms will similarly be analyzed in a blinded manner by a core lab. Coronary segments with a diameter ≥1.5 mm will be included in the analysis. Each segment will be evaluated for the presence or absence of coronary atherosclerosis, defined as any tissue structure \>1 mm\^2 within the coronary artery wall differentiated from the surrounding epicardial tissue, epicardial fat, or the vessel lumen itself. Maximal stenosis ratios as well as atherosclerotic plaque characteristics and CT-derived fractional flow reserve (FFR) will be obtained in each coronary territory. * The paired difference between 18F-flurpiridaz and 82Rb-chloride PET MPI will be evaluating by calculating the receiver operating characteristic area under the curve (ROC AUC) for the sensitivity and specificity of blinded visual reads, automated relative perfusion quantitation, and myocardial blood flow quantification, as well as for image quality and diagnostic certainty assessment.
Interventions
None listed
Sponsors
University of California, Los Angeles
VA Greater Los Angeles Healthcare System
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient scheduled for a clinically indicated 82Rb-chloride PET MPI * Age ≥ 18 years * Ability to provide consent
Exclusion criteria
* Previous participation in a 18F-flurpiridaz clinical trial * Prior myocardial infarction * Prior coronary revascularization (percutaneous coronary intervention and/or coronary artery bypass grafting) * History of orthotopic heart transplantation * Inability to control heart rate \< 65 bpm * Frequent ventricular or atrial ectopy leading to irregular cardiac rhythm * Creatinine ≥ 1.4 mg/dL * Pregnant or breast-feeding status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 18F-Flurpiridaz Diagnostic Performance | From enrollment to completion of CT coronary angiography, an average of 10 days | The diagnostic performance of 18F-flurpiridaz compared to 82Rb-chloride PET myocardial perfusion imaging by expert readers using coronary CT angiography as the reference standard * Diagnostic performances will be analyzed on a per-vessel and a per-patient basis using coronary artery disease (CAD) ≥50% and ≥70% stenoses as significance cutoffs and CT-based fractional flow-reserve (FFR) ≤0.80 at the lesion level and at the distal vessel level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative Perfusion Analysis | From enrollment to completion of 18F-flurpiridaz PET MPI, an average of 10 days | Comparison of automated relative perfusion quantitation markers (summed stress score, summed difference score, total perfusion deficit) between 18F-flurpiridaz and 82Rb-chloride PET MPI using validated software methods |
| Myocardial Blood Flow Quantification | From enrollment to completion of 18F-flurpiridaz PET MPI, an average of 10 days | Comparison of myocardial blood flow and myocardial flow reserve quantification between 18F-flurpiridaz and 82Rb-chloride PET MPI using validated software methods |
Countries
United States
Outcome results
None listed