Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date January 28, 2021
First Posted Date September 21, 2021
Last Update Posted Date September 21, 2021
Actual Study Start Date January 27, 2021
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 9, 2021)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
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 Genetesis Accelerated Registry
Official Title Genetesis Accelerated Registry
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.
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 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.
Condition
  • Acute Myocardial Infarction
  • Acute Coronary Syndrome
Intervention Device: CardioFlux
Magnetocardiography (MCG) is a noninvasive method that measure the magnetic field that arises from the electrical activity of the heart cycle.
Study Groups/Cohorts GEAR cohort
This is a noninvasive study that screens healthy and non-healthy volunteers for cardiovascular disease.
Intervention: Device: CardioFlux
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 9, 2021)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2022
Estimated Primary Completion Date July 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. 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Anthony Senagore, MD 513-715-5045 anthony@genetesis.com
Contact: Samantha Legreaux, M.S. 513-715-5045 sam.legreaux@genetesis.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05051228
Other Study ID Numbers 1000-05
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
Investigators Not Provided
PRS Account Genetesis Inc.
Verification Date September 2021