Clinical trial NCT04732975: Mason Heart Study With MCG
Official title: Mason Heart Study With Magnetocardiography
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Acute Myocardial Injuries
Keywords: ischemia
acute myocardial injuries
CardioFlux
Cardiovascular disease
MCG
Lead sponsor: Genetesis Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-01
Enrollment: 250
Sex: ALL
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: All healthy and non-healthy individuals who are 18 or older.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: specificity and accuracy 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:
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.
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.
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.
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.
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.