A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.
NCT ID: NCT05868902
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2023-08-28
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Negative Cardiac PET
Participants without clinical significant findings for coronary ischemia on cardiac PET scan.
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)
Positive Cardiac PET
Participants with findings indicative of coronary ischemia on cardiac PET scan.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
ALL
No
Sponsors
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Genetesis Inc.
INDUSTRY
Responsible Party
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Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Kettering Health
Kettering, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1000-8
Identifier Type: -
Identifier Source: org_study_id
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