NCT04739254

Magnetocardiography Endocrine Registry

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Genetesis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endocrine Disorder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CardioFlux	Magnetocardiography

Timeline

• Start date: 2020-12-14
• Primary completion: 2022-05-01
• Completion: 2030-05-01
• First posted: 2021-02-04
• Last updated: 2023-10-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study