Clinical trial NCT04739254: Magnetocardiography Endocrine Registry
Official title: Magnetocardiography Endocrine Registry
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Endocrine Disorder
Keywords: endocrine disorders
MCG
Cardiovascular disease
ischemia
CardioFlux
Lead sponsor: Genetesis Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-04
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are at risk for cardiovascular disease due to endocrine disorders.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Accuracy statistics
timeFrame: 12 months
measure: Specificity statistics
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mason
country: United States
facility: Genetesis Facility
state: Ohio
Study officials:
affiliation: Genetesis Inc.
name: Anthony Senagore, M.D.
role: PRINCIPAL_INVESTIGATOR
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