NCT00945048

Brief Summary

The cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac diseases. The current standard methods for the determination of the 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 the electrical velocimetry technique as a new method for determining the CO and to compare this new technique with the Inert Gas Rebreathing Method and with the Magnetic Resonance Tomography

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 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

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
2.7 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
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

2.8 years

First QC Date

July 21, 2009

Last Update Submit

January 15, 2013

Conditions

Cardiac Diseases

Interventions

electrical velocimetryDEVICE

determination of cardiac output by electrical velocimetry

inert gas rebreathingDEVICE

determination of cardiac output by inert gas rebreathing

spirometryDEVICE

spirometry for testing the ventilatory function

cardiac magnetic resonance imaging (CMR)DEVICE

CMR examination which delivers the hemodynamic reference parameters

Eligibility Criteria

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

Consecutive patients with indication for CMR

You may qualify if:

  • Indication for CMR
  • Ability of following instructions for electrical velocimetry test, rebreathing test and spirometry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1st Department of Medicine, University Hospital Mannheim

Mannheim, Baden-Wurttemberg, Germany

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Spirometry

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Joachim Saur, Dr.

    1st Department of Medicine

    STUDY DIRECTOR

  • Jens Kaden, Dr.

    1st Department of Medicine

    STUDY CHAIR

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 21, 2009

First Posted

July 23, 2009

Study Start

June 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

DE(1)