A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.

Study Overview
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Brief Summary
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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.

Official Title
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A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.

Conditions
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Coronary; Ischemic

Intervention / Treatment
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* Device: CardioFlux Magnetocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Life expectancy <1 yrs. due to non-cardiovascular comorbidity

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Negative Cardiac PET<br>Participants without clinical significant findings for coronary ischemia on cardiac PET scan. | Device: CardioFlux Magnetocardiography<br>* The 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)<br>|
| Positive Cardiac PET<br>Participants with findings indicative of coronary ischemia on cardiac PET scan. | Device: CardioFlux Magnetocardiography<br>* The 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetocardiography, Coronary Ischemia