Genetesis Accelerated Registry

Acute Coronary Syndrome Clinical Trial

— GEAR  

Official title:

Genetesis Accelerated Registry

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05051228
• Other study ID #: 1000-05
• Status: Suspended
• Start date: January 27, 2021
• Est. completion date: July 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 purpose of the Genetesis Accelerated Registry (GEAR) study is to understand the potential for magnetocardiography to be utilized as a diagnostic, screening or surveillance tool for heart disease in healthy and non-healthy volunteers. Magnetocardiography (MCG) is a diagnostic method that analyzes and records the magnetic fields of the heart for the detection of various forms of heart disease. There will be a 12-month duration of the study where we propose to collect screening data from approximately 500 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: 500
• Est. completion date: July 2024
• Est. primary completion date: July 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. Patients with present with or have reasonable clinical suspicion of any acute coronary syndrome for which delayed intervention could increase the risk or magnitude of damaged myocardium

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

9. Patients with a language barrier/language difficulties

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• CardioFlux
Magnetocardiography (MCG) is a noninvasive method that measure the magnetic field that arises from the electrical activity of the heart cycle.

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 (4)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Cardioflux diagnosis/screening of ACS	Comparing the accuracy of Cardioflux to current standard of care when diagnosing/screening for ACS	12 months