A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.
Magneto-PET
1 other identifier
observational
300
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2023
CompletedFirst Posted
Study publicly available on registry
May 22, 2023
CompletedStudy Start
First participant enrolled
August 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFebruary 20, 2025
February 1, 2025
1.8 years
May 11, 2023
February 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Negative Cardiac PET
Participants without clinical significant findings for coronary ischemia on cardiac PET scan.
Positive Cardiac PET
Participants with findings indicative of coronary ischemia on cardiac PET scan.
Interventions
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
Men and women age 40 and up with suspected or confirmed coronary ischemia who are scheduled to undergo diagnostic cardiac PET, for non-emergent diagnostic purposes at an enrolling clinical trial center.
You may qualify if:
- 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 may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genetesis Inc.lead
Study Sites (2)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Kettering Health
Kettering, Ohio, 45429, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2023
First Posted
May 22, 2023
Study Start
August 28, 2023
Primary Completion
June 1, 2025
Study Completion
December 31, 2025
Last Updated
February 20, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share