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Non-Invasive Determination of Cardiac Output by Inertgas Rebreathing Method (NICO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00479804
First Posted: May 28, 2007
Last Update Posted: June 5, 2008
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.
Information provided by:
Universitätsmedizin Mannheim
  Purpose
The cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac diseases. The current standard methods for the determination of the CO, however, are either invasive (e.g. right heart catheterization) or technically expendable and expensive (magnetic resonance tomography, MRT). The traditional non-invasive methods of determining the CO by rebreathing of carbon dioxide are easily carried out but suffer from methodical inaccuracies. Therefore the aim of the study at hand was to evaluate a new method for determining the CO by means of the inert gas rebreathing method.

Condition Intervention
Cardiac Diseases Device: inertgas rebreathing Device: spirometry Device: cardiac magnetic resonance imaging (CMR)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Invasive Determination of Cardiac Output by the Inertgas Rebreathing Method Compared With Magnetic Resonance Tomography

Further study details as provided by Universitätsmedizin Mannheim:

Enrollment: 311
Study Start Date: August 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: inertgas rebreathing
    determination of cardiac output by inertgas rebreathing
    Device: spirometry
    spirometry for testing the ventilatory function
    Device: cardiac magnetic resonance imaging (CMR)
    CMR examination which delivers the hemodynamic reference parameters
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Study Population
Consecutive patients with indication for CMR
Criteria

Inclusion Criteria:

  • Indication for CMR
  • Ability of following instructions for rebreathing test
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00479804


Locations
Germany
1st Department of Medicine, University Hospital Mannheim
Mannheim, Baden-Württemberg, Germany, 68167
Sponsors and Collaborators
Universitätsmedizin Mannheim
Investigators
Study Director: Joachim Saur, Dr. 1st Department of Medicine
Study Chair: Jens Kaden, Dr. 1st Deparment of Medicine
  More Information

Responsible Party: Dr. Joachim Saur, University Hospital Mannheim
ClinicalTrials.gov Identifier: NCT00479804     History of Changes
Other Study ID Numbers: 2006-067M-MA
First Submitted: May 25, 2007
First Posted: May 28, 2007
Last Update Posted: June 5, 2008
Last Verified: June 2008

Keywords provided by Universitätsmedizin Mannheim:
indication for CMR

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases