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NCT00479804 Clinical Trial

Non-Invasive Determination of Cardiac Output by Inertgas Rebreathing Method

Cardiac Diseases Clinical Trial

— NICO  

Official title:
Non-Invasive Determination of Cardiac Output by the Inertgas Rebreathing Method Compared With Magnetic Resonance Tomography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00479804
Other study ID # 2006-067M-MA
Secondary ID
Status Completed
Phase N/A
First received May 25, 2007
Last updated June 4, 2008
Start date August 2006
Est. completion date December 2007

Study information
Verified date June 2008
Source Universitätsmedizin Mannheim
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 311
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 14 Years to 90 Years
Eligibility Inclusion Criteria:

- Indication for CMR

- Ability of following instructions for rebreathing test

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• inertgas rebreathing
determination of cardiac output by inertgas rebreathing
• spirometry
spirometry for testing the ventilatory function
• cardiac magnetic resonance imaging (CMR)
CMR examination which delivers the hemodynamic reference parameters

Locations
Country Name City State
Germany 1st Department of Medicine, University Hospital Mannheim Mannheim Baden-Württemberg

Sponsors (1)
Lead Sponsor Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

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