Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04732975
Status:
SUSPENDED
Last Update Posted:
2023-02-23
First Post:
2021-01-27
Brief Title:
Mason Heart Study With MCG
Sponsor:
Genetesis Inc
Organization:
Genetesis Inc
Study Overview
Official Title:
Mason Heart Study With Magnetocardiography
Status:
SUSPENDED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Resourcing
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MHS-MCG
Brief Summary:
Heart disease is the number one cause of death in the United States with over 650000 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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None