Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Precision of the Magnetocardiographer for Data Aquision and Analysis.
This study is currently recruiting participants.
Verified by Mayo Clinic, September 2005
Sponsors and Collaborators: Mayo Clinic
CardioMag Imaging
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00170014
  Purpose

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.


Condition Intervention Phase
Myocardial Ischemia
Device: Magnetocardiograph
Phase III

U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Single Blind, Historical Control, Single Group Assignment, Efficacy Study
Official Title: Reproducibility of Magnetocardiography Measurements Using the Cardiomag Magnetocardiograph System Model 2409 and Its Software for Data Acquisition and Analysis

Further study details as provided by Mayo Clinic:

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

Estimated Enrollment: 60
Study Start Date: October 2004
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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Age less than or equal to 45 years

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170014

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Reordan O De Jesus     507-255-9353        
Principal Investigator: Peter A Smars, M.D. EM            
Sponsors and Collaborators
Mayo Clinic
CardioMag Imaging
Investigators
Principal Investigator: Peter A. Smars, M.D. EM Mayo Clinic
  More Information

Study ID Numbers: 850-04
Study First Received: September 12, 2005
Last Updated: September 12, 2005
ClinicalTrials.gov Identifier: NCT00170014  
Health Authority: United States: Institutional Review Board;   United States: Food and Drug Administration

Study placed in the following topic categories:
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009