Non-Invasive Determination of Cardiac Output by Electrica... | NCT00945048

Studies
Non-Invasive Determination of Cardiac Output by Electrical Velocimetry

NCT00945048

Sponsor

Universitätsmedizin Mannheim

Status

Completed

Last Update Posted

Jan 16, 2013Estimated

Enrollment

220Actual

Phase

Not provided

Conditions

Cardiac Diseases

Interventions

electrical velocimetry
inert gas rebreathing
spirometry
cardiac magnetic resonance imaging (CMR)

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

Jan 2013

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

Jun 2009

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Jul 21, 2009

First Submission Date that Met QC Criteria

Jul 21, 2009

First Posted Date

Jul 23, 2009Estimated

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 15, 2013

Last Update Posted Date

Jan 16, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joachim Saur, Principal Investigator, Universitätsmedizin MannheimPrincipal Investigator

Lead Sponsor

Universitätsmedizin MannheimOTHER

Collaborators

Not provided

Description Module

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

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

220Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
electrical velocimetry	Device	determination of cardiac output by electrical velocimetry
inert gas rebreathing	Device	determination of cardiac output by inert gas rebreathing
spirometry	Device	spirometry for testing the ventilatory function
cardiac magnetic resonance imaging (CMR)	Device	CMR examination which delivers the hemodynamic reference parameters

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Yes

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

Consecutive patients with indication for CMR

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joachim Saur, Dr.	1st Department of Medicine	Study Director
Jens Kaden, Dr.	1st Department of Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
1st Department of Medicine, University Hospital Mannheim		Mannheim	Baden-Wurttemberg		Germany

ID	Term
D006331	Heart Diseases

ID	Term
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D013147	Spirometry

Ancestor Terms

ID	Term
D012129	Respiratory Function Tests
D003948	Diagnostic Techniques, Respiratory System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided