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

NCT05868902 · tracked via the Priya Life Science USA tracker

Sponsor

Genetesis Inc.

Phase

Observational

Started

2023-08-28

Last updated

2025-02-20

Condition(s) studied

Coronary; Ischemic

Investigational drug(s) / intervention(s)

CardioFlux Magnetocardiography

CardioFlux Magnetocardiography: 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)

Study 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

Sex

ALL

Min age

40 Years

Max age

—

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

Primary outcome measure(s)

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

Trial sites (2)

Facility	City	Region	Status
Cleveland Clinic	Cleveland	Ohio	Recruiting
Kettering Health	Kettering	Ohio	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05868902 on ClinicalTrials.gov ↗ ← All trials in the USA