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

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.

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Key information

Conditions

Coronary; Ischemic Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic, Cleveland, Ohio, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CardioFlux Magnetocardiography

Device

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 outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Robert Takla, MD

CONTACT

[email protected]

Zoe E Swann, PhD

CONTACT

[email protected]

4802868695

Sponsors and collaborators

Lead sponsor

Genetesis Inc.

Industry

Registry information

Acronym: Magneto-PET

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: May 22, 2023
Registry last updated: Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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