NCT04732975

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 27, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

3.5 years

First QC Date

January 27, 2021

Last Update Submit

February 21, 2023

Conditions

Acute Myocardial Injuries

Keywords

ischemiaacute myocardial injuriesCardioFluxCardiovascular diseaseMCG

Outcome Measures

Primary Outcomes (1)

  • specificity and accuracy statistics

    analyzing the specificity and accuracy of CardioFlux

    6 months

Interventions

CardioFluxDEVICE

Non-invasive screening for ACS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All healthy and non-healthy individuals who are 18 or older.

You may qualify if:

  • \. ≥ 18 years of age at the time of enrollment.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genetesis Facility

Mason, Ohio, 45040, United States

Location

Related 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.

    PMID: 24667125BACKGROUND

  • 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: 19015988BACKGROUND

  • 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: 15660796BACKGROUND

  • 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.

    PMID: 23336954BACKGROUND

  • 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.

    PMID: 19195500BACKGROUND

MeSH Terms

Conditions

IschemiaCardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological 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 1, 2021

Study Start

December 14, 2020

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)