A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia. (Magneto-PET)

Genetesis

Status: Enrolling

Conditions: Coronary; Ischemic

Treatments: Device: CardioFlux Magnetocardiography

Study type: Observational

Funder types: Industry

Identifiers

NCT05868902

1000-8

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Negative Cardiac PET

Description:

Participants without clinical significant findings for coronary ischemia on cardiac PET scan.

Treatment:

Device: CardioFlux Magnetocardiography

Positive Cardiac PET

Description:

Participants with findings indicative of coronary ischemia on cardiac PET scan.

Treatment:

Device: CardioFlux Magnetocardiography