Women's Assessed Cardiovascular Evaluation With MCG

Cardiac Disease Clinical Trial

— WACE-MCG  

Official title:

Women's Assessed Cardiovascular Evaluation With MCG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04739280
• Other study ID #: 1000-1
• Status: Completed
• Start date: October 15, 2020
• Est. completion date: July 21, 2022

Study information

• Verified date: February 2023
• Source: Genetesis Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 21, 2022
• Est. primary completion date: July 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases
• Ischemia
• Risk Factor, Cardiovascular

Intervention

Device:
• CardioFlux Magnetocardiography
Magnetocardiography

Locations

Country	Name	City	State
United States	Genetesis Facility	Mason	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Genetesis Inc.

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy Statistics	analyzing the accuracy of CardioFlux	6 Months
Primary	Specificity Statistics	analyzing the specificity of CardioFlux	6 months

External Links

•   Women & Cardiovascular Disease