Efficacy of the CMI Magnetocardiograph in Diagnosing Acute Coronary Syndromes in Patients Presenting With High Risk Unstable Angina.
|ClinicalTrials.gov Identifier: NCT00169975|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 18, 2011
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Ischemia||Device: Magnetocardiograph||Phase 3|
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.
|Study Type :||Observational|
|Actual Enrollment :||137 participants|
|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|
|Study Start Date :||August 2004|
|Primary Completion Date :||February 2008|
|Study Completion Date :||February 2008|
- 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. [ Time Frame: 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. [ Time Frame: 1 year ]
- 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. [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169975
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Peter A. Smars, M.D. EM||Mayo Clinic|