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Trial record 6 of 9 for:    cardioflux

Mason Heart Study With MCG (MHS-MCG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04732975
Recruitment Status : Recruiting
First Posted : February 1, 2021
Last Update Posted : September 16, 2021
Information provided by (Responsible Party):
Genetesis Inc.

Tracking Information
First Submitted Date January 27, 2021
First Posted Date February 1, 2021
Last Update Posted Date September 16, 2021
Actual Study Start Date December 14, 2020
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 27, 2021)
specificity and accuracy statistics [ Time Frame: 6 months ]
analyzing the specificity and accuracy of CardioFlux
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Mason Heart Study With MCG
Official Title Mason Heart Study With Magnetocardiography
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All healthy and non-healthy individuals who are 18 or older.
Condition Acute Myocardial Injuries
Intervention Device: CardioFlux
Non-invasive screening for ACS
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 27, 2021)
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
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
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contact: Anthony Senagore, M.D. 513-715-5045
Contact: Samantha Legreaux, M.S. 513-715-5045
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT04732975
Other Study ID Numbers 1000-3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Genetesis Inc.
Study Sponsor Genetesis Inc.
Collaborators Not Provided
Principal Investigator: Anthony Senagore, M.D. Genetesis Inc.
PRS Account Genetesis Inc.
Verification Date September 2021