Women's Assessed Cardiovascular Evaluation With MCG

Study Overview
=================
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.

Official Title
-----------------
Women's Assessed Cardiovascular Evaluation With MCG

Conditions
-----------------
Ischemia, Cardiac Disease, Risk Factor, Cardiovascular

Intervention / Treatment
-----------------
* Device: CardioFlux Magnetocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single center registry for WACE<br>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. | Device: CardioFlux Magnetocardiography<br>* Magnetocardiography<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy Statistics | analyzing the accuracy of CardioFlux | 6 Months | 
| Specificity Statistics | analyzing the specificity of CardioFlux | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular Disease, Magnetic Field Map, CardioFLux, Ischemia, Magnetocardiography, MCG