Recruiting NCT05868902
A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CardioFlux Magnetocardiography.
- Who it may be relevant to
- Registry conditions: Coronary; Ischemic. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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)
Primary outcome measures
- 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 [Time frame: 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 2 centers
- Cleveland Clinic — Cleveland
- Kettering Health — Kettering
Identifiers
NCT: NCT05868902 · 1000-8