Coronary; Ischemic
Conditions
Keywords
Magnetocardiography, Coronary Ischemia
Brief 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.
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)
Sponsors
Genetesis Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Contacts
Primary ContactZoe E Swann, PhD
Backup ContactRobert Takla, MD
Outcome results
None listed