NCT02514863

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

December 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2015

Completed
Last Updated

August 4, 2015

Status Verified

July 1, 2015

Enrollment Period

2.3 years

First QC Date

July 30, 2015

Last Update Submit

July 31, 2015

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • difference between CMR and EV cardiac output measurements

    45 minutes

Secondary Outcomes (1)

  • difference between two consecutive EV cardiac output measurements

    5 minutes

Study Arms (1)

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

Eligibility Criteria

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

patients undergoing CMR

You may qualify if:

  • indication for CMR

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Mannheim

Mannheim, Germany

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 4, 2015

Study Start

December 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

August 4, 2015

Record last verified: 2015-07

Locations

DE(1)