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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Cardiac PET | Participants without clinical significant findings for coronary ischemia on cardiac PET scan. |
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| Positive Cardiac PET | Participants with findings indicative of coronary ischemia on cardiac PET scan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zoe E Swann, PhD | Contact | 4802868695 | zoe.swann@genetesis.com | |
| Robert Takla, MD | Contact | robert.takla@genetesis.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Kettering Health | Recruiting | Kettering | Ohio | 45429 | United States |
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