Right Ventricular DysfunctionNCT03183414
Right Ventricular Dysfunction in Cardiac Surgery Patients
An observational study of Right Ventricular Dysfunction, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial summary
To establish the correlation between echocardiographic parameters of the RV, measured with TEE and the right ventricular ejection fraction (thermodilution). To identify a time in the perioperative process when RV dysfunction occurs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventricular Dysfunction
- What is being tested?
- echocardiographic measurements
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Sep 2017to 30 Jun 2018
- 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: 15 cardiac surgery patients (elective, isolated aortic valve replacement or coronary artery bypass grafting in combination with aortic valve replacement) with a significant preoperative aortic valve stenosis (gradient>40mmHg and/or aortic valve area <1cm2)
Who may be able to join
- cardiac surgery patients
- elective, isolated aortic valve replacement or coronary artery bypass grafting in combination with aortic valve replacement
Who cannot join
- age < 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Right Ventricular Dysfunction in Cardiac Surgery
To establish the correlation between echocardiographic parameters of the RV, measured with TEE and the right ventricular ejection fraction (thermodilution). To identify a time in the perioperative process when RV dysfunction occurs.
Read the detailed description
Measurements with echocardiography were done during cardiac surgery to observe the right ventricular dysfunction in the perioperative process
- Conditions
- Right Ventricular Dysfunction
- Being tested
- echocardiographic measurements
- Keywords
- cardiac surgery, transoesophageal echocardiography
- Medical subject headings
- Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographic measurementsOther
echocardiographic parameters of the RV, measured with TEE and the right ventricular ejection fraction (thermodilution)
| Study group | Role | What they receive |
|---|---|---|
| cardiac surgery patients | cardiac surgery patients with a significant peroperative aortic valve stenosis (gradient>40mmHg and/or aortic valve area <1cm2). During cardiac surgery measurements of right ventricular dysfunction were taken by echocardiography Receives: Other: echocardiographic measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between echocardiographic parameters of the RV, measured with TEE and the RVEF measured with the pulmonary artery catheter
The correlation between echocardiographic parameters of the RV, measured with TEE and the RVEF measured with the pulmonary artery catheter.
Measured: during cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start6 Sep 2017
- Primary completion20 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Ventricular DysfunctionStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matty Koopmans, Frisius Medisch Centrum
- Investigators
- Christiaan Boerma, MD, Principal investigator, MCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183414
- Sponsor's protocol ID
- nWMO 220
- Status last verified
- Nov 2019
- First submitted
- 8 Jun 2017
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not available, patient data is anonym
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricular Dysfunction in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03183414
- Acronym / sponsor ID
- nWMO 220
- Conditions
- Right Ventricular Dysfunction
- Keywords
- cardiac surgery, transoesophageal echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 12 Jun 2017 (actual)
- 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.
To establish the correlation between echocardiographic parameters of the RV, measured with TEE and the right ventricular ejection fraction (thermodilution). To identify a time in the perioperative process when RV dysfunction occurs.
Detailed description
Measurements with echocardiography were done during cardiac surgery to observe the right ventricular dysfunction in the perioperative process
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac surgery patients | – | Other: echocardiographic measurementscardiac surgery patients with a significant peroperative aortic valve stenosis (gradient>40mmHg and/or aortic valve area <1cm2). During cardiac surgery measurements of right ventricular dysfunction were taken by echocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 15 cardiac surgery patients (elective, isolated aortic valve replacement or coronary artery bypass grafting in combination with aortic valve replacement) with a significant preoperative aortic valve stenosis (gradient>40mmHg and/or aortic valve area <1cm2)
Key inclusion criteria (2 listed)
- cardiac surgery patients
- elective, isolated aortic valve replacement or coronary artery bypass grafting in combination with aortic valve replacement
Key exclusion criteria (1 listed)
- age < 18
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 |
|---|---|---|
| echocardiographic measurementsechocardiographic parameters of the RV, measured with TEE and the right ventricular ejection fraction (thermodilution) | Other | cardiac surgery patients |
Primary outcome
The correlation between echocardiographic parameters of the RV, measured with TEE and the RVEF measured with the pulmonary artery catheter
Time frame: during cardiac surgery
The correlation between echocardiographic parameters of the RV, measured with TEE and the RVEF measured with the pulmonary artery catheter.
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 26 Nov 2019.
- Individual participant dataSharing planned: No. not available, patient data is anonym
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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.
Christiaan Boerma, MD principal investigator
MCL
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 Right Ventricular Dysfunction, run by Frisius Medisch Centrum at 1 site in Netherlands.
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 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 26 Nov 2019. 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 Netherlands. 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?
The correlation between echocardiographic parameters of the RV, measured with TEE and the RVEF measured with the pulmonary artery catheter (time frame: during cardiac surgery). 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 26 Nov 2019.