Evaluation of NICOM (Bioreactance) for the Non-invasive D... | NCT02331329

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

NCT02331329

Sponsor

Universitätsmedizin Mannheim

Status

Completed

Last Update Posted

Jan 6, 2015Estimated

Enrollment

41Actual

Phase

Not provided

Conditions

Cardiac Disease

Interventions

NICOM cardiac output measurement
Cardiac MRT cardiac output measurement

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Jan 2, 2015

First Submission Date that Met QC Criteria

Jan 5, 2015

First Posted Date

Jan 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2015

Last Update Posted Date

Jan 6, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
agreement of NICOM and MRT cardiac output measurements		at time of inclusion
precision of NICOM cardiac output measurements		at time of inclusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

indication for cardiac magnetic resonance imaging

Exclusion Criteria:

pace maker
patient unwilling to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Type	Description	Arm Group Labels	Other Names
NICOM cardiac output measurement	Device
Cardiac MRT cardiac output measurement	Device