Clinical trial NCT04739280: Women's Assessed Cardiovascular Evaluation With MCG
Official title: Women's Assessed Cardiovascular Evaluation With MCG
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemia
Cardiac Disease
Risk Factor, Cardiovascular
Keywords: Cardiovascular Disease
Magnetic Field Map
CardioFLux
Ischemia
Magnetocardiography
MCG
Lead sponsor: Genetesis Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-04
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The following describes the targeted population population

≥ 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.)

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.


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

Primary outcomes:
measure: Accuracy Statistics
timeFrame: 6 Months
measure: Specificity Statistics
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mason
country: United States
facility: Genetesis Facility
state: Ohio
Study officials:
affiliation: Genetesis Inc.
name: Anthony Senagore, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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