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Sponsors and Collaborators: |
Mayo Clinic CardioMag Imaging |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00169975 |
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.
Condition | Intervention | Phase |
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Myocardial Ischemia |
Device: Magnetocardiograph |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Double-Blind, Uncontrolled, Single Group Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 200 |
Study Start Date: | August 2004 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patients classified as having Unstable Angina according to the ACC/AHA guidelines.
High Risk (>= 1 of the following) History
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Reordan O De Jesus 507-255-9353 dejesus.reordan@mayo.edu | |
Principal Investigator: Peter A. Smars, M.D EM |
Principal Investigator: | Peter A. Smars, M.D. EM | Mayo Clinic |
Study ID Numbers: | 738-04 |
Study First Received: | September 12, 2005 |
Last Updated: | November 21, 2005 |
ClinicalTrials.gov Identifier: | NCT00169975 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Signs and Symptoms Heart Diseases Myocardial Ischemia Acute Coronary Syndrome Vascular Diseases |
Angina Pectoris Pain Ischemia Angina, Unstable Chest Pain |
Pathologic Processes Cardiovascular Diseases |