NCT02331329

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
Last Updated

January 6, 2015

Status Verified

January 1, 2015

Enrollment Period

11 months

First QC Date

January 2, 2015

Last Update Submit

January 5, 2015

Conditions

Cardiac Disease

Keywords

Accuracy of NICOMprecision of NICOM

Outcome Measures

Primary Outcomes (2)

  • agreement of NICOM and MRT cardiac output measurements

    at time of inclusion

  • precision of NICOM cardiac output measurements

    at time of inclusion

Interventions

NICOM cardiac output measurementDEVICE
Cardiac MRT cardiac output measurementDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hemodynamically and respiratory stable patients undergoing cardiac magnetic resonance imaging with a clinical indication

You may qualify if:

  • indication for cardiac magnetic resonance imaging

You may not qualify if:

  • pace maker
  • patient unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
senior physician

Study Record Dates

First Submitted

January 2, 2015

First Posted

January 6, 2015

Study Start

July 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

January 6, 2015

Record last verified: 2015-01