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NCT05868902 | Recruiting | Coronary; Ischemic

A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.
Sponsor:

Genetesis Inc.

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.

Condition or disease

Coronary; Ischemic

Intervention/treatment

CardioFlux Magnetocardiography

Study Type : Observational
Estimated Enrollment : 300 participants
Official Title : A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.
Actual Study Start Date : August 28, 2023
Estimated Primary Completion Date : June 1, 2025
Estimated Study Completion Date : December 31, 2025

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.

Location Details

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A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, Ohio

Kettering Health

Kettering, Ohio, United States, 45429