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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 : 2023-08-28
Estimated Primary Completion Date : 2025-06-01
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

NCT05868902

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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

Cleveland Clinic

Cleveland, Ohio, United States, 44195

RECRUITING

United States, Ohio

Kettering Health

Kettering, Ohio, United States, 45429