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

Recruiting

• Conditions: Coronary; Ischemic

• 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

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