Non-Invasive Determination of Cardiac Output by Inertgas... | NCT00479804

Studies
Non-Invasive Determination of Cardiac Output by Inertgas Rebreathing Method

NCT00479804

Sponsor

Universitätsmedizin Mannheim

Status

Completed

Last Update Posted

Jun 5, 2008Estimated

Enrollment

311Actual

Phase

Not provided

Conditions

Cardiac Diseases

Interventions

inertgas 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

Jun 2008

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

Aug 2006

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

May 25, 2007

First Submission Date that Met QC Criteria

May 25, 2007

First Posted Date

May 28, 2007Estimated

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

Jun 4, 2008

Last Update Posted Date

Jun 5, 2008Estimated

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). The traditional non-invasive methods of determining the CO by rebreathing of carbon dioxide are easily carried out but suffer from methodical inaccuracies. Therefore the aim of the study at hand was to evaluate a new method for determining the CO by means of the inert gas rebreathing method.

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

Not provided

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

311Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
inertgas rebreathing	Device	determination of cardiac output by inertgas 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 rebreathing test

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Consecutive patients with indication for CMR

Sampling Method

Not provided

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 Deparment of Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
1st Department of Medicine, University Hospital Mannheim		Mannheim	Baden-Wurttemberg	68167	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