Cardiac DiseaseNCT02331329
Evaluation of NICOM (Bioreactance) for the Non-invasive Determination of Cardiac Output
An observational study of Cardiac Disease, run by Universitätsmedizin Mannheim.
Trial summary
Cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac diseases. The current standard methods for the determination of 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 18 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- NICOM cardiac output measurement and Cardiac MRT cardiac output measurement
- Type of treatment
- Medical device
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Jun 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hemodynamically and respiratory stable patients undergoing cardiac magnetic resonance imaging with a clinical indication
Who may be able to join
- indication for cardiac magnetic resonance imaging
Who cannot join
- pace maker
- patient unwilling to participate
About this study
Cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac diseases. The current standard methods for the determination of 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 NICOM (bioreactance) as a new method for determinion of CO and to compare this new technique to MRT.
- Conditions
- Cardiac Disease
- Being tested
- NICOM cardiac output measurement, Cardiac MRT cardiac output measurement
- Keywords
- Accuracy of NICOM, precision of NICOM
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NICOM cardiac output measurementDevice
Cardiac MRT cardiac output measurementDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
agreement of NICOM and MRT cardiac output measurements
Measured: at time of inclusion
precision of NICOM cardiac output measurements
Measured: at time of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Saur, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331329
- Sponsor's protocol ID
- NICOM
- Status last verified
- Jan 2015
- First submitted
- 2 Jan 2015
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of NICOM (Bioreactance) for the Non-invasive Determination of Cardiac Output
- ClinicalTrials.gov ID
- NCT02331329
- Acronym / sponsor ID
- NICOM
- Conditions
- Cardiac Disease
- Keywords
- Accuracy of NICOM, precision of NICOM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 Jan 2015 (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.
Cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac diseases. The current standard methods for the determination of 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 NICOM (bioreactance) as a new method for determinion of CO and to compare this new technique to MRT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hemodynamically and respiratory stable patients undergoing cardiac magnetic resonance imaging with a clinical indication
Key inclusion criteria (1 listed)
- indication for cardiac magnetic resonance imaging
Key exclusion criteria (2 listed)
- pace maker
- patient unwilling to participate
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 |
|---|---|---|
| NICOM cardiac output measurement | Device | – |
| Cardiac MRT cardiac output measurement | Device | – |
Primary outcome
agreement of NICOM and MRT cardiac output measurements
Time frame: at time of inclusion
precision of NICOM cardiac output measurements
Time frame: at time of inclusion
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 6 Jan 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by Universitätsmedizin Mannheim.
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 1 inclusion and 2 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 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
agreement of NICOM and MRT cardiac output measurements (time frame: at time of inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 6 Jan 2015.