Genetesis Accelerated Registry (GEAR)

Genetesis

Status: Suspended

Conditions: Acute Coronary Syndrome; Acute Myocardial Infarction

Treatments: Device: CardioFlux

Study type: Observational

Funder types: Industry

Identifiers

NCT05051228

1000-05

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

500 participants in 1 patient group

GEAR cohort

Description:

This is a noninvasive study that screens healthy and non-healthy volunteers for cardiovascular disease.

Treatment:

Device: CardioFlux