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Magnetocardiography Endocrine Registry

Magnetocardiography Endocrine Registry

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04739254
Acronym
MACENDOR
Enrollment
250
Registered
2021-02-04
Start date
2020-12-14
Completion date
2030-05-01
Last updated
2023-10-12

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

Conditions

Endocrine Disorder

Keywords

endocrine disorders, MCG, Cardiovascular disease, ischemia, CardioFlux

Brief summary

Endocrine disorders like Type 2 diabetes mellitus (T2DM) represent complex cardiometabolic disease processes affecting approximately 462 million individuals worldwide and is associated with a two- to three-fold increase in cardiovascular mortality. Individuals with T2DM are at an increased risk of developing cardiovascular disease. Research has shown individuals with T2DM and no previous history of coronary artery disease are still at similar risk rates for cardiovascular events as patients with a prior myocardial infarction. The MAgenetoCardiography ENDOcrine Registry (MACENDOR) study is designed to collect CardioFlux scans on a select group of volunteers who are high-risk patients with endocrine disorders. CardioFlux is used as a noninvasive magnetocardiography (MCG) tool that analyzes and records the magnetic fields of the heart to screen volunteers for 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 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

DIAGNOSTIC_TESTCardioFlux

Magnetocardiography

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
No

Inclusion criteria

1. ≥ 18 years of age at the time of enrollment 2. Patients deemed at risk for cardiovascular disease from endocrine disorders

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy statistics12 monthsanalyzing the accuracy of CardioFlux
Specificity statistics12 monthsanalyzing the specificity of CardiFlux

Countries

United States

Outcome results

None listed

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