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

Recruiting

• Conditions: Coronary; Ischemic
• Interventions: Device: CardioFlux Magnetocardiography

• Registration Number: NCT05868902
• Lead Sponsor: Genetesis Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-11
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-22
• Study Start: 2023-08-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Negative Cardiac PET	CardioFlux Magnetocardiography	Participants without clinical significant findings for coronary ischemia on cardiac PET scan.
Positive Cardiac PET	CardioFlux Magnetocardiography	Participants with findings indicative of coronary ischemia on cardiac PET scan.

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (2)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Kettering Health; 🇺🇸 Kettering, Ohio, United States