A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.
Genetesis Inc.
300 participants
Aug 28, 2023
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria5
- 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
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Interventions
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)
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05868902