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Sponsors and Collaborators: |
Mayo Clinic CardioMag Imaging |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00170027 |
A magnetocardiograph (MCG) is a medical device capable of recording the magnetic fields that arise from the electrical activity of the heart. It was developed for the general purpose as a noninvasive, non-contact diagnostic tool of obstructive coronary artery disease (CAD), and especially of cardiac ischemia. The overall objective of the present study is to demonstrate the efficacy of this MCG device in the diagnosis of lack of oxygen to an area of the heart (as in an Heart attack) in patients presenting with chest pain.
Condition | Intervention | Phase |
---|---|---|
Myocardial Ischemia |
Device: Magnetocardiograph |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Double-Blind, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Safety and Efficacy of the CMI Magnetocardiograph Model 2409 for Diagnosing Coronary Heart Disease |
Estimated Enrollment: | 250 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | September 2005 |
The CMI-2409 magnetocardiograph (MCG) is an FDA-approved medical device capable of noninvasive recording of magnetic fields arising from the electrical activity of the heart. This system was developed by CMI for the general purpose of noninvasive, non-contact diagnostics of obstructive coronary artery disease (CAD), and especially of cardiac ischemia. The overall objective of the present study is to demonstrate the efficacy of this MCG device and of the associated MCG method for the detection and diagnosis of ischemia in chest pain patients.
The primary objective is to demonstrate that the diagnostic accuracy of the MCG device and method is equivalent to or better than that of a standard 12-lead ECG for detecting the presence of ischemia in patients presenting with chest pain of unknown etiology. In this study the rest MCG data will be analyzed and compared to the results of a rest ECG.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Subjects with chest pain syndrome or angina equivalent
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: | 999-03 |
Study First Received: | September 12, 2005 |
Last Updated: | March 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00170027 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Pathologic Processes Cardiovascular Diseases |