Cardiac DiseasesNCT01639313
Comparison of Nexfin Pulse Contour Analysis and Cardiac Magnetic Resonance Imaging for the Measurement of Cardiac Output
An observational study of Cardiac Diseases, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
A growing interest in monitoring cardiac output (CO) non-invasively has emerged, however its determination has been difficult using the standard approaches. The aim of the study is to evaluate the accuracy and precision of pulse contour analysis (PCA) as compared to cardiac magnetic resonance imaging (CMR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Diseases
- How many people
- 39 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Nov 2011
- 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 stable patients undergoing CMR
Who may be able to join
- indication for CMR
Who cannot join
- contraindication for CMR
- claustrophobia
- no consent obtained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Arterial Pulse Contour Analysis Using Nexfin a New Option in the Non-invasive Measurement of Cardiac Output? - A Pilot Study
A growing interest in monitoring cardiac output (CO) non-invasively has emerged, however its determination has been difficult using the standard approaches. The aim of the study is to evaluate the accuracy and precision of pulse contour analysis (PCA) as compared to cardiac magnetic resonance imaging (CMR).
- Conditions
- Cardiac Diseases
- Medical subject headings
- Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startJun 2011
- Primary completionNov 2011
- Study completionNov 2011
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
- 39 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
- NCT01639313
- Sponsor's protocol ID
- PCA_CMR_MA
- Status last verified
- Jul 2012
- First submitted
- 9 Jul 2012
- Last updated
- 12 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Arterial Pulse Contour Analysis Using Nexfin a New Option in the Non-invasive Measurement of Cardiac Output? - A Pilot Study
- ClinicalTrials.gov ID
- NCT01639313
- Acronym / sponsor ID
- PCA_CMR_MA
- Conditions
- Cardiac Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 12 Jul 2012 (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.
A growing interest in monitoring cardiac output (CO) non-invasively has emerged, however its determination has been difficult using the standard approaches. The aim of the study is to evaluate the accuracy and precision of pulse contour analysis (PCA) as compared to cardiac magnetic resonance imaging (CMR).
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 stable patients undergoing CMR
Key inclusion criteria (1 listed)
- indication for CMR
Key exclusion criteria (3 listed)
- contraindication for CMR
- claustrophobia
- no consent obtained
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
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 12 Jul 2012.
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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 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 1 inclusion and 3 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 12 Jul 2012. 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 12 Jul 2012.