Cardiovascular DiseaseNCT02514863
Electrode Placement in Electrical Velocimetry
An observational study of Cardiovascular Disease, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
Electrical velocimetry (EV) is one of the latest adaptions of impedance cardiography showing diverging results. With electrode position being a suspected factor influencing measurement accuracy or reproducibility for impedance cardiography in general, no data is currently available on altering the gap of the two lower… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 92 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2009to Apr 2012
- 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: patients undergoing CMR
Who may be able to join
- indication for CMR
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Electrode Placement on Electrical Velocimetry Cardiac Output Measurements
Electrical velocimetry (EV) is one of the latest adaptions of impedance cardiography showing diverging results. With electrode position being a suspected factor influencing measurement accuracy or reproducibility for impedance cardiography in general, no data is currently available on altering the gap of the two lower electrodes in EV. Reference values were determined using the non-invasive gold-standard cardiac magnetic resonance imaging (CMR).
- Conditions
- Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing CMR | Assessment of hemodynamic function using: * CMR * EV with an inter-electrode gap (lower pair) of 5 cm * EV with an inter-electrode gap (lower pair) of 15 cm |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference between CMR and EV cardiac output measurements
Measured: 45 minutes
Secondary outcomes (1)
difference between two consecutive EV cardiac output measurements
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2015 (estimated)
- Study startDec 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular 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
- 92 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
- NCT02514863
- Sponsor's protocol ID
- 2009-MA-electrodes
- Status last verified
- Jul 2015
- First submitted
- 30 Jul 2015
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Electrode Placement on Electrical Velocimetry Cardiac Output Measurements
- ClinicalTrials.gov ID
- NCT02514863
- Acronym / sponsor ID
- 2009-MA-electrodes
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 4 Aug 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.
Electrical velocimetry (EV) is one of the latest adaptions of impedance cardiography showing diverging results. With electrode position being a suspected factor influencing measurement accuracy or reproducibility for impedance cardiography in general, no data is currently available on altering the gap of the two lower electrodes in EV. Reference values were determined using the non-invasive gold-standard cardiac magnetic resonance imaging (CMR).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing CMR | – | –Assessment of hemodynamic function using: * CMR * EV with an inter-electrode gap (lower pair) of 5 cm * EV with an inter-electrode gap (lower pair) of 15 cm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing CMR
Key inclusion criteria (1 listed)
- indication for CMR
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
difference between CMR and EV cardiac output measurements
Time frame: 45 minutes
1 secondary outcome
difference between two consecutive EV cardiac output measurements
Time frame: 5 minutes
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 4 Aug 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.
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 Cardiovascular Disease, 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 1 inclusion and 1 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 4 Aug 2015. 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.
What does the primary outcome measure?
difference between CMR and EV cardiac output measurements (time frame: 45 minutes). 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 4 Aug 2015.