Women's Assessed Cardiovascular Evaluation With MCG

Completed

• Conditions: Cardiac Disease; Ischemia; Risk Factor, Cardiovascular
• Interventions: Device: CardioFlux Magnetocardiography

• Registration Number: NCT04739280
• Lead Sponsor: Genetesis Inc.

Brief Summary

Cardiovascular disease (CVD) is the number one cause of death for women over the age of 25, accounting for 1 of every 3 female deaths. Research has shown that while hypertension in women is less controlled, they are also less likely to be identified with ischemic heart disease and when diagnosed treated less aggressively than men. Moreover, women who are diagnosed with breast cancer have an increased risk for cardiovascular disease. The Women's Assessed Cardiovascular Evaluation with MCG (WACE-MCG) study is designed to collect CardioFlux scans on a select group of female volunteers who are Ms. Medicine patients. CardioFlux is used as a noninvasive MCG tool that analyzes and records the magnetic fields of the heart to detect various forms of heart disease. There will be a 12-month duration of the study where we propose to collect screening data from approximately 200 volunteers who present to the Genetesis facility for a 5-minute CardioFlux MCG 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: 2020-10-15
• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-04
• Primary Completion: 2022-07-21
• Study Completion: 2022-07-21
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

≥ 18 years of age at the time of enrollment. Female Patients deemed at risk for cardiovascular disease (breast cancer survivors, patients referred to cardiologists, prior COVID-19 patients, etc.)

Exclusion Criteria

< 18 years of age Patients unable to fit into device Non-ambulatory patients Positive response on CardioFlux Pre-Screening Form Patients with claustrophobia or unable to lie supine for 5 minutes Pregnant women Poor candidate for follow-up (e.g. no access to phone) Prisoners

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single center registry for WACE	CardioFlux Magnetocardiography	We propose a single center registry for patients requiring diagnostic, screening, or surveillance for potential or existing cardiac illness. All eligible patients will undergo an MCG with periodic follow-ups. No treatment decisions will be based on the MCG findings, until CardioFlux has appropriate FDA labelling for clinical use.

Primary Outcome Measures

Name	Time	Method
Accuracy Statistics	6 Months	analyzing the accuracy of CardioFlux
Specificity Statistics	6 months	analyzing the specificity of CardioFlux

Trial Locations

Locations (1)

Genetesis Facility; 🇺🇸 Mason, Ohio, United States