Genetesis Accelerated Registry

Suspended

• Conditions: Acute Myocardial Infarction; Acute Coronary Syndrome
• Interventions: Device: CardioFlux

• Registration Number: NCT05051228
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-27
• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-21
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GEAR cohort	CardioFlux	This is a noninvasive study that screens healthy and non-healthy volunteers for cardiovascular disease.

Primary Outcome Measures

Name	Time	Method
Accuracy of Cardioflux diagnosis/screening of ACS	12 months	Comparing the accuracy of Cardioflux to current standard of care when diagnosing/screening for ACS

Trial Locations

Locations (1)

Genetesis Facility; 🇺🇸 Mason, Ohio, United States