NCT04739280

Women's Assessed Cardiovascular Evaluation With MCG

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Genetesis Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ischemia
• Cardiac Disease
• Risk Factor, Cardiovascular

Interventions

Type	Name	Description
DEVICE	CardioFlux Magnetocardiography	Magnetocardiography

Timeline

• Start date: 2020-10-15
• Primary completion: 2022-07-21
• Completion: 2022-07-21
• First posted: 2021-02-04
• Last updated: 2023-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study