Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients

Completed

• Conditions: Acute Coronary Syndrome; Myocardial Infarction
• Interventions: Diagnostic Test: Magnetocardiography

• Registration Number: NCT03255772
• Lead Sponsor: Genetesis Inc.

Brief Summary

Genetesis is a cardiac diagnostics company which presents a novel magnetocardiogram (MCG) analysis system called CardioFlux. This investigation presents a new, noninvasive diagnostic option to use MCG for rapid diagnosis of acute coronary syndrome. Data from the Cardioflux system will be compared with stress testing methods as well as the results of cardiac catheterization to identify patients with myocardial ischemia.

This is a prospective observational single-blinded convenience pilot study of 100 patients placed in the Clinical Decision Unit (CDU) for evaluation of chest pain at St. John Hospital and Medical Center (Detroit, MI).

Patients enrolled in the study will also have a 30 and 180 day follow up for analysis of adverse cardiac events.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-15
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-21
• Primary Completion: 2017-12-30
• Study Completion: 2018-05-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-26
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

Low and intermediate risk ED patients presenting with chest pain of possible cardiac origin who have a negative first troponin result and non-diagnostic ECG that are to be placed in the Cardiac Diagnostic Unit (CDU) for further evaluation.

Exclusion Criteria

1. ≤ 18 years of age
2. Patients unable to fit into device
3. Non-ambulatory patients
4. Patients with any implantable device or metal in the thorax area (e.g. pacemaker, AICD, bullet fragments in thorax)
5. Patients with claustrophobia
6. Pregnant women
7. Poor candidate for follow-up
8. Prisoners
9. Repeat participants

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute Chest pain	Magnetocardiography	All patients admitted to the Clinical Decision Unit presenting to the Emergency Department (ED) with chest pain with risk factors suggesting a possible cardiac etiology.

Primary Outcome Measures

Name	Time	Method
Identification of Active Myocardial Ischemia	1 week	Comparison of Magnetocardiography (MCG) and imaging of magnetic field/current will be directly compared to cardiac catheterization data in those patients who undergo this procedure.

Secondary Outcome Measures

Name	Time	Method
Medium term Adverse Cardiac Events	6 months	In patients discharged from the cardiac observation unit with a negative stress test result, how does MCG results correlate with major adverse cardiac events (MACE) at 30 days and 6 months following discharge? MACE will be defined as acute myocardial infarction, coronary revascularization, and all-cause death.

Trial Locations

Locations (1)

St. John Hospital and Medical Center; 🇺🇸 Detroit, Michigan, United States