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| Name | Class |
|---|---|
| CardioMag Imaging | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetocardiograph | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
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*ACC/AHA Guidelines for Unstable Angina: High Risk (≥1 of the following)
History
Patients classified as having high-risk unstable angina at presentation in the ED will be approached for enrollment in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Peter A. Smars, M.D. EM | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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