NCT05868902Recruiting

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

Genetesis Inc.

Start Date

8/28/2023

Completion Date

12/31/2025

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 Criteria

Age Range: 40 years to No maximum

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

Interventions

DEVICE

CardioFlux Magnetocardiography

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Conditions

Coronary; Ischemic

Locations

Cleveland Clinic

Cleveland, Ohio 44195

United States

Kettering Health

Kettering, Ohio 45429

United States