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Mason Heart Study With MCG

Mason Heart Study With Magnetocardiography

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04732975
Acronym
MHS-MCG
Enrollment
250
Registered
2021-02-01
Start date
2020-12-14
Completion date
2024-06-30
Last updated
2023-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Injuries

Keywords

ischemia, acute myocardial injuries, CardioFlux, Cardiovascular disease, MCG

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.

Interventions

Non-invasive screening for ACS

Sponsors

Genetesis Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1\. ≥ 18 years of age at the time of enrollment.

Exclusion criteria

1. \< 18 years of age 2. Patients unable to fit into device 3. Non-ambulatory patients 4. Positive response on CardioFlux Pre-Screening Form 5. Patients with claustrophobia or unable to lie supine for 5 minutes 6. Pregnant women 7. Poor candidate for follow-up (e.g. no access to phone) 8. Prisoners

Design outcomes

Primary

MeasureTime frameDescription
specificity and accuracy statistics6 monthsanalyzing the specificity and accuracy of CardioFlux

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026