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

Coronary; Ischemic Clinical Trial

— Magneto-PET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868902
• Other study ID #: 1000-8
• Status: Recruiting
• Start date: August 28, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Genetesis Inc.
• Contact: Melanie Gruen, M.S.
• Phone: 8594684273
• Email: melanie.gruen[@]genetesis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary; Ischemic
• Ischemia

Intervention

Device:
• 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)

Locations

Country	Name	City	State
United States	Kettering Health	Kettering	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Genetesis Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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