Evaluation of NICOM (Bioreactance) for the Non-invasive Determination of Cardiac Output

Cardiac Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331329
• Other study ID #: NICOM
• Status: Completed
• Phase: N/A
• First received: January 2, 2015
• Last updated: January 5, 2015
• Start date: July 2013
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

Cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac diseases. The current standard methods for the determination of CO, however, are either invasive (e.g. right heart catheterization) or technically expendable and expensive (magnetic resonance tomography, MRT). Therefore, the aim of the study at hand was to evaluate NICOM (bioreactance) as a new method for determinion of CO and to compare this new technique to MRT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• indication for cardiac magnetic resonance imaging

Exclusion Criteria:

• pace maker

• patient unwilling to participate

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Device:
• NICOM cardiac output measurement

• Cardiac MRT cardiac output measurement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	agreement of NICOM and MRT cardiac output measurements		at time of inclusion	No
Primary	precision of NICOM cardiac output measurements		at time of inclusion	No