Registry collecting data on cardiac PET and CardioFlux Magnetocardiography for coronary ischemia detection
A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.
This study is collecting information from patients who might have coronary ischemia to see if a new heart imaging method can help find this condition better than the standard tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Genetesis Inc. Industry-sponsored |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Trial ID | NCT05868902 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to gather diagnostic data from patients suspected of having coronary ischemia by utilizing standard cardiac PET imaging. It will also explore the potential role of CardioFlux Magnetocardiography in enhancing the detection of this condition. The study involves multiple centers and focuses on patients who have recently undergone cardiac PET. By analyzing the collected data, researchers hope to improve understanding and diagnostic capabilities for coronary ischemia.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older with a clinical suspicion of myocardial ischemia who have recently completed a cardiac PET.
Not a fit: Patients with implanted ferromagnetic devices or those unable to lie supine for the required duration may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic techniques for coronary ischemia, potentially enhancing patient outcomes.
How similar studies have performed: While the use of cardiac PET is well-established, the application of CardioFlux Magnetocardiography in this context is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio and 1 other locations
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Kettering Health — Kettering, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Zoe E Swann, PhD
- Email: zoe.swann@genetesis.com
- Phone: 4802868695
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.