Mason Heart Study With MCG
- Conditions
- Acute Myocardial Injuries
- Registration Number
- NCT04732975
- Lead Sponsor
- Genetesis Inc.
- Brief Summary
Heart disease is the number one cause of death in the United States, with over 650,000 deaths in 2019 alone. Many healthy individuals possess key risk factors for heart disease which include but are not limited to high blood pressure, high cholesterol, family history of heart disease, and diabetes. The Mason Heart Study-MCG (MHS-MCG) registry is designed to collect magnetocardiography (MCG) scans on a select group of healthy volunteers who work for the city of Mason, OH, with and without cardiac symptoms, illnesses, and/or risk factors. CardioFlux is used as a noninvasive MCG tool that analyzes and records the magnetic fields of the heart to detect various forms of heart disease. There will be a 12-month duration of the study where we propose to collect screening data from approximately 250 volunteers who present to the Genetesis facility for a 5-minute CardioFlux MCG scan. The volunteers will be contacted at intervals over a 1-year period for follow-up data and may choose whether or not they would like to provide follow-up data or participate in another scan.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 250
- ≥ 18 years of age at the time of enrollment.
- < 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method specificity and accuracy statistics 6 months analyzing the specificity and accuracy of CardioFlux
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Genetesis Facility
🇺🇸Mason, Ohio, United States