Safety and Efficacy of MCG for Diagnosing Coronary Heart Disease
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|ClinicalTrials.gov Identifier: NCT00170027|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 15, 2011
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Ischemia||Device: Magnetocardiograph||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Safety and Efficacy of the CMI Magnetocardiograph Model 2409 for Diagnosing Coronary Heart Disease|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
- Primary endpoint will be final clinical diagnosis of ischemia by the primary treating physician. This decision will be based upon evaluation of symptoms, clinical presentation, 12-lead ECG, cardiac enzymes (Troponin I or CKMB).
- 1. Correlation of MCG with anatomic patency and TIMI flow on coronary angiography
- 2. Correlation of MCG with functional and laboratory tests
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00170027
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Peter A. Smars, M.D. EM||Mayo Clinic|