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Genetesis Accelerated Registry (GEAR)

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: NCT05051228
Recruitment Status : Recruiting
First Posted : September 21, 2021
Last Update Posted : September 21, 2021
Information provided by (Responsible Party):
Genetesis Inc.

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 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.

Condition or disease Intervention/treatment
Acute Myocardial Infarction Acute Coronary Syndrome Device: CardioFlux

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetesis Accelerated Registry
Actual Study Start Date : January 27, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Group/Cohort Intervention/treatment
GEAR cohort
This is a noninvasive study that screens healthy and non-healthy volunteers for cardiovascular disease.
Device: CardioFlux
Magnetocardiography (MCG) is a noninvasive method that measure the magnetic field that arises from the electrical activity of the heart cycle.

Primary Outcome Measures :
  1. Accuracy of Cardioflux diagnosis/screening of ACS [ Time Frame: 12 months ]
    Comparing the accuracy of Cardioflux to current standard of care when diagnosing/screening for ACS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All volunteers presenting to the Genetesis facility (5950 Mason Montgomery Rd, Suite 1400, Mason, OH 45040) meeting the inclusion criteria for performance of a magnetocardiograph scan for diagnosis, risk assessment, or treatment monitoring due to cardiac illness (as determined by the Investigators) may participate. All other exclusion criteria are not specified contraindications for the device. If a patient has metal implants or implanted devices in your torso (e.g., pacemaker) or large amounts of implanted metal in other parts of their body, these may make their scan unreadable. There are no risks to the patient if they enter CardioFlux with metal. This scenario would simply require a re-scan, if the metal can be removed, or an unusable scan.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05051228

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Contact: Anthony Senagore, MD 513-715-5045
Contact: Samantha Legreaux, M.S. 513-715-5045

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United States, Ohio
Genetesis Facility Recruiting
Mason, Ohio, United States, 45040
Contact: Samantha Legreaux, M.S.    513-715-5045   
Sponsors and Collaborators
Genetesis Inc.
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Responsible Party: Genetesis Inc. Identifier: NCT05051228    
Other Study ID Numbers: 1000-05
First Posted: September 21, 2021    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Genetesis Inc.:
acute myocardial injuries
Cardiovascular disease
Additional relevant MeSH terms:
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Myocardial Infarction
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases