Mason, Ohio 45040

  • Risk Factor, Cardiovascular

Purpose:

To compare the diagnostic accuracy, sensitivity and specificity of a CardioFlux magnetic field map study as a potential diagnostic, screening, or surveillance tool for patients with cardiac symptoms, illnesses, and/or risk factors.


Study summary:

To measure the test performance characteristics of the CardioFluxTM Magnetocardiograph in the assessment of various patients' potential cardiac illnesses for refined diagnostic information versus screening for risk factors, as well as patients requiring monitoring of pre-existing cardiac illnesses to record in a patient registry maintained by Genetesis. All patients presenting to the Genetesis facility (5950 Mason Montgomery Rd, Suite 1400, Mason, OH 45040) meeting the inclusion criteria for performance of a magnetocardiograph scan for diagnosis, risk assessment, or treatment monitoring due to cardiac illness (as determined by the Investigators) may participate. The outcome measures will be NPV, PPV, sensitivity, specificity for CardioFlux magnetocardiograph against the patient's standard of care test results based on the indication for the scan (diagnosis, screening, or surveillance). Patients will be contacted at intervals over a 1 year period for follow up data for the patient registry, based on consideration of a patient's clinical disposition. The patient may choose whether or not to provide follow up data or to participate in another scan.


Criteria:

Inclusion Criteria: ≥ 18 years of age at the time of enrollment. Female Patients deemed at risk for cardiovascular disease (breast cancer survivors, patients referred to cardiologists, prior COVID-19 patients, etc.) Exclusion Criteria: < 18 years of age Patients unable to fit into device Non-ambulatory patients Positive response on CardioFlux Pre-Screening Form Patients with claustrophobia or unable to lie supine for 5 minutes Pregnant women Poor candidate for follow-up (e.g. no access to phone) Prisoners


NCT ID:

NCT04739280


Primary Contact:

Principal Investigator
Anthony Senagore, M.D.
Genetesis Inc.

Anthony Senagore, M.D.
Phone: 513-715-5045
Email: anthony@genetesis.com


Backup Contact:

Email: sam.legreaux@genetesis.com
Samantha Legreaux, M.S.
Phone: 513-715-5045


Location Contact:

Mason, Ohio 45040
United States

Sam Legreaux, M.S.
Phone: 513-715-5045
Email: sam.legreaux@genetesis.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 24, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.