Recruiting

Cardiac PET

Sponsor:

Genetesis Inc.

Code:

NCT05868902

Conditions

Coronary; Ischemic

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

CardioFlux Magnetocardiography

Study Details

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.

Conditions

Coronary; Ischemic

Study ID

NCT05868902

Start date

Aug 28, 2023

Status verified date

Feb, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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

CardioFlux Magnetocardiography

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)

Primary outcome measure

  • 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 [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Zoe E Swann, PhD

4802868695zoe.swann@genetesis.com

Robert Takla, MD

robert.takla@genetesis.com

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Cynthia Rosser

(216) 444-4372rosserc@ccf.org

Principal Investigator:

Wael Jaber, MD

Kettering Health

Recruiting

Kettering, Ohio, United States, 45429

Contacts

Allison Dymacek

allison.dymacek@ketteringhealth.org

Principal Investigator:

Damien Valencia, MD

More Information

Sponsor

Genetesis Inc.

Last update posted

Feb 20, 2025

Last verified

Feb, 2025

Keywords

  • Magnetocardiography
  • Coronary Ischemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Genetesis Inc. on 2025-02-20.