Women's Assessed Cardiovascular Evaluation With MCG

NCT04739280 | Completed FDA Device

• 1 other identifier: 1000-1
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia; Cardiac Disease; Risk Factor, Cardiovascular

Keywords

Cardiovascular Disease; Magnetic Field Map; CardioFLux; Ischemia; Magnetocardiography; MCG

Outcome Measures

Primary Outcomes (2)

• Accuracy Statistics

  analyzing the accuracy of CardioFlux

  6 Months

• Specificity Statistics

  analyzing the specificity of CardioFlux

  6 months

Study Arms (1)

Single center registry for WACE

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

Interventions

CardioFlux Magnetocardiography DEVICE

Magnetocardiography

Single center registry for WACE

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants must identify as Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.)

You may qualify if:

• ≥ 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.)

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Genetesis Inc.: lead

Study Sites (1)

Genetesis Facility

Mason, Ohio, 45040, United States

Location

Related Publications (8)

• Duda-Pyszny D, Trzeciak P, Gasior M. Coronary artery disease in women. Kardiochir Torakochirurgia Pol. 2018 Mar;15(1):44-48. doi: 10.5114/kitp.2018.74675. Epub 2018 Mar 28.

  PMID: 29681961 BACKGROUND

• Garcia M, Mulvagh SL, Merz CN, Buring JE, Manson JE. Cardiovascular Disease in Women: Clinical Perspectives. Circ Res. 2016 Apr 15;118(8):1273-93. doi: 10.1161/CIRCRESAHA.116.307547.

  PMID: 27081110 BACKGROUND

• Merz CN, Kelsey SF, Pepine CJ, Reichek N, Reis SE, Rogers WJ, Sharaf BL, Sopko G. The Women's Ischemia Syndrome Evaluation (WISE) study: protocol design, methodology and feasibility report. J Am Coll Cardiol. 1999 May;33(6):1453-61. doi: 10.1016/s0735-1097(99)00082-0.

  PMID: 10334408 BACKGROUND

• Baldassarre LA, Raman SV, Min JK, Mieres JH, Gulati M, Wenger NK, Marwick TH, Bucciarelli-Ducci C, Bairey Merz CN, Itchhaporia D, Ferdinand KC, Pepine CJ, Walsh MN, Narula J, Shaw LJ; American College of Cardiology's Cardiovascular Disease in Women Committee. Noninvasive Imaging to Evaluate Women With Stable Ischemic Heart Disease. JACC Cardiovasc Imaging. 2016 Apr;9(4):421-35. doi: 10.1016/j.jcmg.2016.01.004.

  PMID: 27056162 BACKGROUND

• Barish R, Lynce F, Unger K, Barac A. Management of Cardiovascular Disease in Women With Breast Cancer. Circulation. 2019 Feb 19;139(8):1110-1120. doi: 10.1161/CIRCULATIONAHA.118.039371.

  PMID: 30779651 BACKGROUND

• Chaikovsky I, Hailer B, Sosnytskyy V, Lutay M, Mjasnikov G, Kazmirchuk A, Bydnyk M, Lomakovskyy A, Sosnytskaja T. Predictive value of the complex magnetocardiographic index in patients with intermediate pretest probability of chronic coronary artery disease: results of a two-center study. Coron Artery Dis. 2014 Sep;25(6):474-84. doi: 10.1097/MCA.0000000000000107.

  PMID: 24667125 BACKGROUND

• Goernig M, Liehr M, Tute C, Schlosser M, Haueisen J, Figulla HR, Leder U. Magnetocardiography based spatiotemporal correlation analysis is superior to conventional ECG analysis for identifying myocardial injury. Ann Biomed Eng. 2009 Jan;37(1):107-11. doi: 10.1007/s10439-008-9598-5. Epub 2008 Nov 18.

  PMID: 19015988 BACKGROUND

• Hailer B, Chaikovsky I, Auth-Eisernitz S, Schafer H, Van Leeuwen P. The value of magnetocardiography in patients with and without relevant stenoses of the coronary arteries using an unshielded system. Pacing Clin Electrophysiol. 2005 Jan;28(1):8-16. doi: 10.1111/j.1540-8159.2005.09318.x.

  PMID: 15660796 BACKGROUND

Related Links

• Women \& Cardiovascular Disease

MeSH Terms

Conditions

Ischemia; Heart Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anthony Senagore, M.D.

  Genetesis Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 4, 2021
• Study Start: October 15, 2020
• Primary Completion: July 21, 2022
• Study Completion: July 21, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)