A multicenter observational data development registry collecting diagnostic measures via standard of care (SOC) cardiac PET in order gain a better understanding of how CardioFlux MCG may be used in the detection of coronary ischemia.
Willing to provide informed consent
Male or female, aged 40 and up (inclusive) at the time of enrollment
Clinical suspicion of myocardial ischemia that clinician desired cardiac PET
Completed cardiac PET within 2 weeks prior to study enrollment
Patients unable to fit into CardioFlux device.
Patients unable to lie supine for 5 minutes.
Patients with implanted ferromagnetic objects above the costal margin of the rib cage (implanted pacemakers, cardioverter/defibrillators, infusion pumps, and/or neuro stimulators). NOTE: Sternotomy wires stents are acceptable
Ongoing atrial fibrillation or atrial flutter
Men and women age 40 and up with suspected or confirmed coronary ischemia who are scheduled to undergo diagnostic cardiac PET, for non-emergent diagnostic purposes at an enrolling clinical trial center.
Case-control
Retrospective
CardioFlux Magnetocardiography
DeviceThe device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with a cloud processing software. CardioFlux devices are owned by Genetesis and are currently cleared for the acquisition, display, and analysis of magnetic fields generated by cardiac electrical activity (K182571, FDA clearance letter available for download online)
To collect diagnostic data using SOC diagnostic cardiac PET testing for the purposes of gaining a better understanding of how CardioFlux MCG may be used in the detection of coronary ischemia
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