Precision of the Magnetocardiographer for Data Aquision and Analysis.
Primary Purpose
Myocardial Ischemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Magnetocardiograph
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocardial Ischemia
Eligibility Criteria
Age less than or equal to 45 years
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
The objective of our study is to evaluate inter-examiner reproducibility in the MCG results retrieved from data acquisition and analysis by two examiners. HTS-MCG measurements will be obtained from healthy AND diseased subjects in an unshielded clinical
Secondary Outcome Measures
Full Information
NCT ID
NCT00170014
First Posted
September 12, 2005
Last Updated
February 14, 2011
Sponsor
Mayo Clinic
Collaborators
CardioMag Imaging
1. Study Identification
Unique Protocol Identification Number
NCT00170014
Brief Title
Precision of the Magnetocardiographer for Data Aquision and Analysis.
Official Title
Reproducibility of Magnetocardiography Measurements Using the Cardiomag Magnetocardiograph System Model 2409 and Its Software for Data Acquisition and Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
CardioMag Imaging
4. Oversight
5. Study Description
Brief Summary
magnetocardiography has been extensively studied focusing on the possible clinical applications of the device. Evaluating the precision of a device is a prerequisite condition to know what are significant changes and how can these be trusted. A respectable reproducibility study for the MCG measurements is crucial for this new device to be used for clinical applications. In this study, we will focus on a critical portion of the heart cycle assessing for changes in time of the computerized analysis of this phase and comparing the analysis done by two examiners.
Detailed Description
The studies involving magnetocardiography have almost exclusively focused on evaluating possible clinical applications of the device. Leder et al saw the need for investigating the reproducibility of High Temperature Superconducting (HTS-)MCG measurements. They tested 18 healthy volunteers, stating that assessment of the reproducibility of HTS-MCGs in the normal heart is a prerequisite condition for the definition of significant levels of changes which, for instance, may be observed in serial measurements of patients suffering from acute coronary syndromes. They also pointed out the potentially strong electromagnetic interference inside a hospital, likely to be very different from the noise found in engineering laboratories where the MCGs are originally calibrated and tested. A respectable reproducibility for the MCG measurements is crucial for clinical applications. Leder et al studied the reproducibility of QRS complexes, ST segments, and T waves. They found that the reproducibility of the measurements in the depolarization phase was high, whereas the reproducibility of their repolarization readings was considerably lower. The results led Leder et al to conclude that further technical development was needed to improve signal-to-noise ratio allowing for clinical application of repolarization abnormalities for recognizing Acute Coronary Syndromes. In this study, we will focus on the repolarization phase by assessing the reproducibility of the T wave only. Comparison of scores and results based on computer analyses will provide the basis for our evaluation. Visual interpretations by the two examiners will also be compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Magnetocardiograph
Primary Outcome Measure Information:
Title
The objective of our study is to evaluate inter-examiner reproducibility in the MCG results retrieved from data acquisition and analysis by two examiners. HTS-MCG measurements will be obtained from healthy AND diseased subjects in an unshielded clinical
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Age less than or equal to 45 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A. Smars, M.D. EM
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
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Precision of the Magnetocardiographer for Data Aquision and Analysis.
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