Cardiac DiseasesNICONCT00479804
Non-Invasive Determination of Cardiac Output by Inertgas Rebreathing Method
An observational study of Cardiac Diseases, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Diseases
- What is being tested?
- inertgas rebreathing, spirometry and cardiac magnetic resonance imaging (CMR)
- Type of treatment
- Medical device
- How many people
- 311 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2006to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Consecutive patients with indication for CMR
Who may be able to join
- Indication for CMR
- Ability of following instructions for rebreathing test
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
1st Department of Medicine, University Hospital Mannheim
Mannheim, Baden-Wurttemberg, 68167
About this study
Official title: Non-Invasive Determination of Cardiac Output by the Inertgas Rebreathing Method Compared With Magnetic Resonance Tomography
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.
- Conditions
- Cardiac Diseases
- Being tested
- inertgas rebreathing, spirometry, cardiac magnetic resonance imaging (CMR)
- Keywords
- indication for CMR
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inertgas rebreathingDevice
determination of cardiac output by inertgas rebreathing
spirometryDevice
spirometry for testing the ventilatory function
cardiac magnetic resonance imaging (CMR)Device
CMR examination which delivers the hemodynamic reference parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startAug 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Investigators
- Joachim Saur, Dr., Study director, 1st Department of MedicineJens Kaden, Dr., Study chair, 1st Deparment of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479804
- Sponsor's protocol ID
- 2006-067M-MA
- Acronym
- NICO
- Status last verified
- Jun 2008
- First submitted
- 25 May 2007
- Last updated
- 5 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Determination of Cardiac Output by the Inertgas Rebreathing Method Compared With Magnetic Resonance Tomography
- ClinicalTrials.gov ID
- NCT00479804
- Acronym / sponsor ID
- NICO / 2006-067M-MA
- Conditions
- Cardiac Diseases
- Keywords
- indication for CMR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 28 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients with indication for CMR
Key inclusion criteria (2 listed)
- Indication for CMR
- Ability of following instructions for rebreathing test
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inertgas rebreathingdetermination of cardiac output by inertgas rebreathing | Device | – |
| spirometryspirometry for testing the ventilatory function | Device | – |
| cardiac magnetic resonance imaging (CMR)CMR examination which delivers the hemodynamic reference parameters | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Saur, Dr. study director
1st Department of Medicine
Jens Kaden, Dr. study chair
1st Deparment of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Diseases, run by Universitätsmedizin Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2008.