Skip to main content
OpenTrials
Completed

NCT Number: NCT04739280

Women's Assessed Cardiovascular Evaluation With MCG

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Genetesis Facility

Mason, Ohio, 45040, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CardioFlux Magnetocardiography

Device

Magnetocardiography

Primary outcomes

  1. Accuracy Statistics

    Time frame: 6 Months

    analyzing the accuracy of CardioFlux

  2. Specificity Statistics

    Time frame: 6 months

    analyzing the specificity of CardioFlux

Sponsors and collaborators

Lead sponsor

Genetesis Inc.

Industry

Registry information

Acronym: WACE-MCG

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 4, 2021
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.