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

Conditions

• Coronary; Ischemic

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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)

Study Details

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.

Key Dates

Start date

Aug 28, 2023

Status verified

Feb 2025

Primary completion

Jun 1, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

300 participants (estimated)

Arms

• Arm: Negative Cardiac PET
  Participants without clinical significant findings for coronary ischemia on cardiac PET scan.
• Arm: Positive Cardiac PET
  Participants with findings indicative of coronary ischemia on cardiac PET scan.

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

• Zoe E Swann, PhD
  4802868695
  [email protected]
• Robert Takla, MD
  [email protected]

Locations (2)

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