Stress Echo and Electric Impedance Tomography (EIT) Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01168557
Recruitment Status : Completed
First Posted : July 23, 2010
Last Update Posted : November 27, 2013
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:
Electric Impedance Tomography (EIT) is a technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax.It is a radiation free, non- invasive and portable lung imaging technique. Impedance changes in lung ventilation as well as in lung perfusion can be shown. To investigate lung perfusion by EIT measurements, cardiac output measured by routinely undergone stress echocardiography at rest and stress are compared to parameters measured by EIT.

Condition or disease Intervention/treatment Phase
Electric Impedance Tomography Stress Echocardiography Cardiac Output Ventilation Perfusion Device: EIT (Electrical Impedance Tomography) Not Applicable

Detailed Description:
In 15 patients who routinely have to undergo stress echocardiography Electric Impedance Tomography (EIT) measurements are performed parallel to measurements of cardiac output at rest, low stress generated by a dosage of 10µg dobutamine, at peak generated by a dosage between 20-40µg dobutamine (individually)and at relaxation(pulse <100). Therefore prior to the examination a rubber belt with 16 integrated electrocardiographic electrodes is placed around the thorax at the fifth or sixth intercostal space, connected with an EIT device. EIT data are generated by application of a small alternating electrical current of 5mA and 50kHz and are stored and analyzed offline on a personal computer. Changes due to ventilation as well as changes due to perfusion will be measured by EIT. Cardiac output will be retrospectively compared to parameters of the EIT. EIT data are stored in a database and pseudonymized evaluated in relationship to routinely measured stress echocardiography data.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Stress Echo and Electric Impedance Tomography (EIT) Pilot Study to Investigate the Influence of Cardiac Output on Parameters of the EIT
Study Start Date : July 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: Stress-Echo and EIT
Patients who routinely undergo stress-echocardiography will additionally be measured by EIT using a rubber belt, which will be placed around their chest
Device: EIT (Electrical Impedance Tomography)
EIT measurement; concomitant to stress echocardiography (about 45 minutes) EIT measurements (1 minute) are performed at rest, at low dobutamine stress, at peak and at relaxation

Primary Outcome Measures :
  1. influence of cardiac output on EIT measurements (feasibility) [ Time Frame: single measurement of 45 minutes ]
    It will be investigated if a change in cardiac output, which is measured by stress-echocardiography by dobutamine, has an influence on the parameters determined by EIT measurements.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • male patients >18 years who routinely have to undergo stress echocardiography
  • ejection fraction >50%
  • able to give informed consent

Exclusion Criteria:

  • restrictive lung diseases
  • active implants and heart pace makers and implanted converter defibrillator
  • foreign metallic objects in the thorax
  • Not adequate quality of imaging of stress echocardiography

Information from the National Library of Medicine

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 identifier (NCT number): NCT01168557

Medical Clinic I, University Hospital Aachen
Aachen, Nordrhein-Westfalen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Principal Investigator: Stefan Krueger, MD, Assoc. Prof. RWTH Aachen University of Cardiology, Pneumology and Angiology, Aachen, NRW, Germany

Responsible Party: RWTH Aachen University Identifier: NCT01168557     History of Changes
Other Study ID Numbers: Stress Echo - EIT
First Posted: July 23, 2010    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013

Keywords provided by RWTH Aachen University:
electric impedance tomography