Efficacy of the CMI Magnetocardiograph in Diagnosing Acute Coronary Syndromes in Patients Presenting With High Risk Unstable Angina.

Mayo Clinic

Status: Completed

Conditions: Myocardial Ischemia

Treatments: Device: Magnetocardiograph

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00169975

738-04

Details and patient eligibility

About

A magnetocardiograph (MCG) is a device capable of recording of magnetic fields arising from the electrical activity of the heart with traces similar to an electrocardiogram (ECG). This system was developed as a noninvasive, non-contact diagnostics of obstructive coronary artery disease (CAD), and especially of lack of oxygen in the heart as in a heart attack. The overall objective of this study is to demonstrate the efficacy of this MCG device for the detection and diagnosis of lack of oxygen of the heart in patients with chest pain.

Full description

Coronary Artery Disease is the leading cause of death in the United States. The non invasive detection of Acute Coronary Syndromes (ACS's) remains a clinical challenge. Electrocardiogram (ECG) may only diagnose myocardial infarction in 50 % of the cases. Magnetocardiography is a new and noninvasive method capable of measuring and mapping the magnetic field that is generated during the cardiac cycle. The electric current is affected by ischemic damage, which in turn alters the magnetic field. The magnetic field is not affected by body tissues, unlike the surface current measurements in ECG.

Comparisons: The diagnostic accuracy of the CMI-Magnetocardiograph will be compared to that of the ECG in diagnosing High Risk Unstable Angina.

Enrollment: 137 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients classified as having High Risk Unstable Angina according to the ACCIAHA guidelines.
• Age ≥ 18 years.

Exclusion criteria

• Hemodynamically unstable patients.
• Patients who just prior to or just after admission exhibit tachycardia with heart rates exceeding 150 bpm.
• Patients with third degree AV Block.
• Patients with pacemakers or internal cardiac defibrillators.
• Patients who cannot lie in a supine position for the MCG examination.
• Patients who refuse entry into the registry