Women's Assessed Cardiovascular Evaluation With MCG
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cardiac Disease
- Ischemia
- Risk Factor, Cardiovascular
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
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 t...
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.
Tracking Information
- NCT #
- NCT04739280
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Anthony Senagore, M.D. Genetesis Inc.