Precision of the Magnetocardiographer for Data Aquision and Analysis.

This study has been completed.
Sponsor:
Collaborator:
CardioMag Imaging
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00170014
First received: September 12, 2005
Last updated: February 14, 2011
Last verified: February 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Reproducibility of Magnetocardiography Measurements Using the Cardiomag Magnetocardiograph System Model 2409 and Its Software for Data Acquisition and Analysis

Resource links provided by NLM:


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

Enrollment: 12
Study Start Date: October 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00170014

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
CardioMag Imaging
Investigators
Principal Investigator: Peter A. Smars, M.D. EM Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00170014     History of Changes
Other Study ID Numbers: 850-04
Study First Received: September 12, 2005
Last Updated: February 14, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014