Magnetocardiography Endocrine Registry
Paused
Conditions studied: Endocrine Disorder
In brief
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.
Key facts
- Study ID
- NCT04739254
- Run by
- Genetesis Inc.
- People needed
- 250
- Starts
- 2020-12-14
- Expected to finish
- 2030-05-01
- Last updated by the study team
- 2023-10-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 18 years of age at the time of enrollment
- Patients deemed at risk for cardiovascular disease from endocrine disorders
You may not qualify if…
- < 18 years of age
- Patients unable to fit into device
- Non-ambulatory patients
- Positive response(s) on CardioFlux Pre-Screening Form
- Patients with claustrophobia or unable to lie supine for five minutes
- Pregnant women
- Poor candidates for follow-up (e.g., no access to phone)
- Prisoners
Where it is running
- Genetesis Facility — Mason, Ohio, United States
Full record on ClinicalTrials.gov
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