NCT04739267

Acute Coronary Syndrome CardioFlux TM Study (ACCMED)

The Acute Coronary Syndrome Accelerated CardioFlux TM Magnetocardiography-based Early Disposition Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 390 (actual)
• Sponsor: Genetesis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Approximately 16.5 million people suffer from coronary artery disease (CAD) and about 10 million present each year to emergency departments with symptoms like chest pain and shortness of breath, commonly suggestive of acute coronary syndrome (ACS). To clinically assess ACS risk in these patients, there are typically 2-6 hours of emergency room evaluation, followed by 6-42 hours of an observation period prior to discharge. The clinical pathway includes: 1) 1-3 ECG's; 2) serial troponins (1 and 3 hours vs 1 and 6 hours); and 3) other pertinent diagnostic information, including but not limited to echocardiography, stress testing and/or CT Angiography. Patients who are evaluated, have presented with a low risk for ACS, and maintain negative diagnostic results can potentially be discharged within 6 hours. However, 20%-40% of patients who fall into indeterminate diagnostic categories will require longer observation periods or admission of 12-48 hours which result in the use of expensive imaging and provocative testing, such as stress testing. The purpose of ACCMED is to measure the efficacy of Magnetocardiography (MCG) as a diagnostic tool to rule-in/rule-out myocardial ischemia in patients with suspicion of an acute coronary syndrome who have a HEART Score \> 2 and to allow safe and timely disposition of the patient to an appropriate level of care.

Conditions

• Acute Myocardial Injuries

Interventions

Type	Name	Description
DEVICE	CardioFlux	Not an intervention

Timeline

• Start date: 2021-01-27
• Primary completion: 2022-11-30
• Completion: 2023-03-03
• First posted: 2021-02-04
• Last updated: 2023-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study