MedTrace Logo

Genetesis Accelerated Registry

NCT05051228 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2023-02-23

No results posted yet for this study

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.

Conditions

  • Acute Myocardial Infarction
  • Acute Coronary Syndrome

Interventions

DEVICE

CardioFlux

Magnetocardiography (MCG) is a noninvasive method that measure the magnetic field that arises from the electrical activity of the heart cycle.

Sponsors & Collaborators

  • Genetesis Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2024-07-31
Completion
2024-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05051228 on ClinicalTrials.gov