Magnetocardiography Endocrine Registry

Suspended

• Conditions: Endocrine Disorder

• Registration Number: NCT04739254
• Lead Sponsor: Genetesis Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-14
• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-04
• Primary Completion: 2022-05-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-12
• Study Completion: 2030-05-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy statistics	12 months	analyzing the accuracy of CardioFlux
Specificity statistics	12 months	analyzing the specificity of CardiFlux

Trial Locations

Locations (1)

Genetesis Facility; 🇺🇸 Mason, Ohio, United States