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Trial record 1 of 1 for:    NCT05868902
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A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia. (Magneto-PET)

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ClinicalTrials.gov Identifier: NCT05868902
Recruitment Status : Recruiting
First Posted : May 22, 2023
Last Update Posted : August 31, 2023
Sponsor:
Information provided by (Responsible Party):
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 Intervention/treatment
Coronary; Ischemic Device: CardioFlux Magnetocardiography

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Group/Cohort Intervention/treatment
Negative Cardiac PET
Participants without clinical significant findings for coronary ischemia on cardiac PET scan.
Device: 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)

Positive Cardiac PET
Participants with findings indicative of coronary ischemia on cardiac PET scan.
Device: 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 Measures :
  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 [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05868902


Contacts
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Contact: Melanie Gruen, M.S. 8594684273 melanie.gruen@genetesis.com

Locations
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United States, Ohio
Kettering Health Recruiting
Kettering, Ohio, United States, 45429
Contact: Allison Dymacek       allison.dymacek@ketteringhealth.org   
Principal Investigator: Nathaniel Dittoe, MD         
Sponsors and Collaborators
Genetesis Inc.
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Responsible Party: Genetesis Inc.
ClinicalTrials.gov Identifier: NCT05868902    
Other Study ID Numbers: 1000-8
First Posted: May 22, 2023    Key Record Dates
Last Update Posted: August 31, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Genetesis Inc.:
Magnetocardiography
Coronary Ischemia
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes