Actively Recruiting
A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia
Led by Genetesis Inc. · Updated on 2025-02-20
300
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting data from patients who undergo standard cardiac PET scans to better understand how the CardioFlux Magnetocardiography (MCG) device might help detect coronary ischemia. This observational registry includes participants with and without evidence of coronary ischemia on their cardiac PET scans to gather diagnostic information. The study is sponsored by Genetesis Inc. and focuses on patients suspected of myocardial ischemia. Participants will have previously completed a cardiac PET scan within two weeks before joining the study. The CardioFlux device, a magnetocardiography scanner paired with cloud processing software, will be used to record magnetic signals generated by the heart's electrical activity. The study groups include those with negative cardiac PET results and those with positive findings indicating ischemia. During the study, participants will be assessed using their standard cardiac PET data alongside CardioFlux MCG readings. The primary goal is to collect diagnostic data over 24 months to evaluate the potential use of the CardioFlux device in detecting coronary ischemia. Participants will be monitored for their ability to complete the procedure, including lying still for five minutes, and safety considerations related to implanted devices and health conditions are observed.
CONDITIONS
Brief Title
A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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); sternotomy wires stents are acceptable
- Ongoing atrial fibrillation or atrial flutter
- Life expectancy less than 1 year due to non-cardiovascular comorbidity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Within 2 weeks prior to enrollment
Participants undergo cardiac PET scans as part of their standard clinical care to assess for coronary ischemia.
1 cardiac PET scan (routine clinical care)
Duration - Single visit at enrollment
Participants receive a CardioFlux Magnetocardiography scan to collect diagnostic data alongside their cardiac PET results.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
2
Kettering Health
Kettering, Ohio, United States, 45429
Actively Recruiting
Research Team
Z
Zoe E Swann, PhD
R
Robert Takla, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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