Mason Heart Study With MCG

Acute Myocardial Injuries Clinical Trial

— MHS-MCG  

Official title:

Mason Heart Study With Magnetocardiography

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04732975
• Other study ID #: 1000-3
• Status: Suspended
• Start date: December 14, 2020
• Est. completion date: June 2024

Study information

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

Clinical Trial Summary

Heart disease is the number one cause of death in the United States, with over 650,000 deaths in 2019 alone. Many healthy individuals possess key risk factors for heart disease which include but are not limited to high blood pressure, high cholesterol, family history of heart disease, and diabetes. The Mason Heart Study-MCG (MHS-MCG) registry is designed to collect magnetocardiography (MCG) scans on a select group of healthy volunteers who work for the city of Mason, OH, with and without cardiac symptoms, illnesses, and/or risk factors. 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 250 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: Suspended
• Enrollment: 250
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. = 18 years of age at the time of enrollment.

Exclusion Criteria:

1. < 18 years of age

2. Patients unable to fit into device

3. Non-ambulatory patients

4. Positive response on CardioFlux Pre-Screening Form

5. Patients with claustrophobia or unable to lie supine for 5 minutes

6. Pregnant women

7. Poor candidate for follow-up (e.g. no access to phone)

8. Prisoners

Related Conditions & MeSH terms

• Acute Myocardial Injuries

Intervention

Device:
• CardioFlux
Non-invasive screening for ACS

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 (5)

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

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

Kwong JS, Leithauser B, Park JW, Yu CM. Diagnostic value of magnetocardiography in coronary artery disease and cardiac arrhythmias: a review of clinical data. Int J Cardiol. 2013 Sep 1;167(5):1835-42. doi: 10.1016/j.ijcard.2012.12.056. Epub 2013 Jan 19. — View Citation

Lim HK, Kwon H, Chung N, Ko YG, Kim JM, Kim IS, Park YK. Usefulness of magnetocardiogram to detect unstable angina pectoris and non-ST elevation myocardial infarction. Am J Cardiol. 2009 Feb 15;103(4):448-54. doi: 10.1016/j.amjcard.2008.10.013. Epub 2008 Dec 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	specificity and accuracy statistics	analyzing the specificity and accuracy of CardioFlux	6 months

External Links

•   About Heart Disease