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

Myocardial Ischemia Clinical Trial

Official title:

Efficacy of the CMI Magnetocardiograph in Diagnosing Acute Coronary Syndromes in Patients Presenting With High Risk Unstable Angina as Defined by ACC/AHA Guidelines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169975
• Other study ID #: 738-04
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: July 15, 2011
• Start date: August 2004
• Est. completion date: February 2008

Study information

• Verified date: July 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Device:
• Magnetocardiograph
MCG and ECG recordings sequentially at the four pre-defined bed positions and watches the real-time magnetocardiogram traces on the computer screen. At each position, nine sensors record MCG data, thus forming a 3 x 3 point grid square with point-to-point separation of 40 mm. The number of cardiac cycles recorded at each position should be adequate for signal averaging. Recording time per position is typically 90 seconds. At the end of 4 sequential recordings, raw, unfiltered MCG data are stored.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	CardioMag Imaging

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Determine the discriminatory ability of the scores derived from the MCG evaluation to discriminate between patients with versus without a clinical diagnosis of ACS at discharge.		1 year	No
Primary	2. Compare the discriminatory ability of scores derived from the MCG, the troponin level, and the ECG results, separately or in combination, to discriminate between patients with without a diagnosis of ACS at discharge.		1 year	No
Secondary	1. Evaluate the sensitivity of the MCG to detect an ultimate diagnosis of ACS, MI, CHF, or death at 1 month, 6 months, and 1 year following discharge.		1 year	No