Electrode Placement in Electrical Velocimetry | NCT02514863

Studies
Electrode Placement in Electrical Velocimetry

NCT02514863

Sponsor

Universitätsmedizin Mannheim

Status

Completed

Last Update Posted

Aug 4, 2015Estimated

Enrollment

92Actual

Phase

Not provided

Conditions

Cardiovascular Disease

Interventions

Not provided

Countries

Germany

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

Jul 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

Dec 2009

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Jul 30, 2015

First Submission Date that Met QC Criteria

Jul 31, 2015

First Posted Date

Aug 4, 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

Jul 31, 2015

Last Update Posted Date

Aug 4, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joachim Saur, Principal Investigator, Universitätsmedizin MannheimPrincipal Investigator

Lead Sponsor

Universitätsmedizin MannheimOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Electrical velocimetry (EV) is one of the latest adaptions of impedance cardiography showing diverging results. With electrode position being a suspected factor influencing measurement accuracy or reproducibility for impedance cardiography in general, no data is currently available on altering the gap of the two lower electrodes in EV. Reference values were determined using the non-invasive gold-standard cardiac magnetic resonance imaging (CMR).

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

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergoing CMR		Assessment of hemodynamic function using: CMR EV with an inter-electrode gap (lower pair) of 5 cm EV with an inter-electrode gap (lower pair) of 15 cm

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
difference between CMR and EV cardiac output measurements		45 minutes

Secondary Outcomes

Measure	Description	Time Frame
difference between two consecutive EV cardiac output measurements		5 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

indication for CMR

Exclusion Criteria:

pregnancy

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

patients undergoing CMR

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Mannheim		Mannheim			Germany

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided