NCT04732975

Mason Heart Study With MCG

Mason Heart Study With Magnetocardiography

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Genetesis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acute Myocardial Injuries

Interventions

Type	Name	Description
DEVICE	CardioFlux	Non-invasive screening for ACS

Timeline

• Start date: 2020-12-14
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2021-02-01
• Last updated: 2023-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study