Ventricular Function, RightNCT01968252
Speckle-tracking Tricuspid Annular Plane Systolic Excursion
An observational study of Ventricular Function, Right, run by University of Nebraska at 1 site in United States.
Trial summary
The study is designed to validate the use of speckle-tracking echocardiography to measure tricuspid annular plane systolic excursion as a measurement of right ventricular function during transesophageal echocardiography. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Ventricular Function, Right
- What is being tested?
- Concurrent TTE and TEE
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2014to 1 Nov 2015
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects will be scheduled to undergo a surgical procedure requiring general anesthesia and either due to subject factors or procedure factors, the use of intraoperative transesophageal echocardiographic monitoring will occur. These subjects will then have both transesophageal and transthoracic echocardiographic measurements of one variable of right ventricular function to validate the results from the transesophageal window.
Who may be able to join
- All subjects who are scheduled to undergo general anesthesia and concurrently will be managed with intraoperative transesophageal echocardiography will be included in potential subjects.
Who cannot join
- Subjects who do not have adequate transesophageal and/or transthoracic imaging windows to allow for accurate analysis of tricuspid annular motion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Validation of Speckle-tracking Echocardiography Measurements of Tricuspid Annular Plane Systolic Excursion During Transesophageal Echocardiography
The study is designed to validate the use of speckle-tracking echocardiography to measure tricuspid annular plane systolic excursion as a measurement of right ventricular function during transesophageal echocardiography.
Read the detailed description
- Use of speckle-tracking echocardiography to validate tricuspid annular plane systolic excursion measurements with transesophageal echocardiography.
- This study intends to validate the use of speckle-tracking echocardiography to measure the distance the tricuspid annulus moves during the systolic phase. The guideline articles regarding right ventricular function suggest m-mode measurements from the transthoracic approach and the same measurements may underestimate the actual distance on transesophageal echocardiography. This speckle-tracking technology will allow this distance to be measured despite its often non-parallel motion to the ultrasound beam, which otherwise limits the reliability of the valve recorded.
- All subjects undergoing a planned surgical procedure in which the use of transesophageal echocardiography would be used regardless for their management.
- No interventions, only evaluation of the measurements obtained with transthoracic echocardiography compared to transesophageal echocardiography.
- No follow-up, study will be completed at the time of image acquisition.
- Conditions
- Ventricular Function, Right
- Being tested
- Concurrent TTE and TEE
- Keywords
- Speckle-tracking echocardiography, Transthoracic echocardiography, Transesophageal echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent TTE and TEEOther
All subjects will undergo both transthoracic echocardiography and transesophageal echocardiography to compare the results of measurements obtained from both imaging locations.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Patient | All patients in the cohort will be scheduled to undergo a planned surgical procedure in which the subject will undergo general anesthesia and the procedure and/or the patient will require transesophageal echocardiographic monitoring for the procedure. Receives: Other: Concurrent TTE and TEE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speckle-tracking derived tricuspid annular plane systolic excursion with transesophageal echocardiography
Speckle-tracking derived tricuspid annular plane systolic excursion with transesophageal echocardiography
Measured: 1 hour
Secondary outcomes (3)
M-mode derived tricuspid annular plane systolic excursion with transesophageal echocardiography
M-mode derived tricuspid annular plane systolic excursion with transesophageal echocardiography
Measured: 1 hour
M-mode derived tricuspid annular plane systolic excursion with transthoracic echocardiography
M-mode derived tricuspid annular plane systolic excursion with transthoracic echocardiography
Measured: 1 hour
Speckle-tracking derived tricuspid annular plane systolic excursion with transthoracic echocardiography
Speckle-tracking derived tricuspid annular plane systolic excursion with transthoracic echocardiography
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study start1 May 2014
- Primary completion1 Feb 2015
- Study completion1 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ventricular Function, RightStudies 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
- Cross-sectional
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas W Markin, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968252
- Sponsor's protocol ID
- 0107-14-EP
- Status last verified
- Aug 2023
- First submitted
- 16 Oct 2013
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Ahmad H, Mor-Avi V, Lang RM, Nesser HJ, Weinert L, Tsang W, Steringer-Mascherbauer R, Niel J, Salgo IS, Sugeng L. Assessment of right ventricular function using echocardiographic speckle tracking of the tricuspid annular motion: comparison with cardiac magnetic resonance. Echocardiography. 2012;29(1):19-24. doi: 10.1111/j.1540-8175.2011.01519.x. Epub 2011 Oct 4.
PubMed 21967480Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. doi: 10.1016/j.echo.2005.10.005. No abstract available.
PubMed 16376782Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
PubMed 20620859Mor-Avi V, Lang RM, Badano LP, Belohlavek M, Cardim NM, Derumeaux G, Galderisi M, Marwick T, Nagueh SF, Sengupta PP, Sicari R, Smiseth OA, Smulevitz B, Takeuchi M, Thomas JD, Vannan M, Voigt JU, Zamorano JL. Current and evolving echocardiographic techniques for the quantitative evaluation of cardiac mechanics: ASE/EAE consensus statement on methodology and indications endorsed by the Japanese Society of Echocardiography. J Am Soc Echocardiogr. 2011 Mar;24(3):277-313. doi: 10.1016/j.echo.2011.01.015.
PubMed 21338865
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Speckle-tracking Echocardiography Measurements of Tricuspid Annular Plane Systolic Excursion During Transesophageal Echocardiography
- ClinicalTrials.gov ID
- NCT01968252
- Acronym / sponsor ID
- 0107-14-EP
- Conditions
- Ventricular Function, Right
- Keywords
- Speckle-tracking echocardiography, Transthoracic echocardiography, Transesophageal echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 May 2014 (actual)
- Primary completion
- 1 Feb 2015 (actual)
- Study completion
- 1 Nov 2015 (actual)
- First posted
- 23 Oct 2013 (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 study is designed to validate the use of speckle-tracking echocardiography to measure tricuspid annular plane systolic excursion as a measurement of right ventricular function during transesophageal echocardiography.
Detailed description
- Use of speckle-tracking echocardiography to validate tricuspid annular plane systolic excursion measurements with transesophageal echocardiography.
- This study intends to validate the use of speckle-tracking echocardiography to measure the distance the tricuspid annulus moves during the systolic phase. The guideline articles regarding right ventricular function suggest m-mode measurements from the transthoracic approach and the same measurements may underestimate the actual distance on transesophageal echocardiography. This speckle-tracking technology will allow this distance to be measured despite its often non-parallel motion to the ultrasound beam, which otherwise limits the reliability of the valve recorded.
- All subjects undergoing a planned surgical procedure in which the use of transesophageal echocardiography would be used regardless for their management.
- No interventions, only evaluation of the measurements obtained with transthoracic echocardiography compared to transesophageal echocardiography.
- No follow-up, study will be completed at the time of image acquisition.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Patient | – | Other: Concurrent TTE and TEEAll patients in the cohort will be scheduled to undergo a planned surgical procedure in which the subject will undergo general anesthesia and the procedure and/or the patient will require transesophageal echocardiographic monitoring for the procedure. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects will be scheduled to undergo a surgical procedure requiring general anesthesia and either due to subject factors or procedure factors, the use of intraoperative transesophageal echocardiographic monitoring will occur. These subjects will then have both transesophageal and transthoracic echocardiographic measurements of one variable of right ventricular function to validate the results from the transesophageal window.
Key inclusion criteria (1 listed)
- All subjects who are scheduled to undergo general anesthesia and concurrently will be managed with intraoperative transesophageal echocardiography will be included in potential subjects.
Key exclusion criteria (1 listed)
- Subjects who do not have adequate transesophageal and/or transthoracic imaging windows to allow for accurate analysis of tricuspid annular motion.
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 |
|---|---|---|
| Concurrent TTE and TEEAll subjects will undergo both transthoracic echocardiography and transesophageal echocardiography to compare the results of measurements obtained from both imaging locations. | Other | Intraoperative Patient |
Primary outcome
Speckle-tracking derived tricuspid annular plane systolic excursion with transesophageal echocardiography
Time frame: 1 hour
Speckle-tracking derived tricuspid annular plane systolic excursion with transesophageal echocardiography
3 secondary outcomes
M-mode derived tricuspid annular plane systolic excursion with transesophageal echocardiography
Time frame: 1 hour
M-mode derived tricuspid annular plane systolic excursion with transthoracic echocardiography
Time frame: 1 hour
Speckle-tracking derived tricuspid annular plane systolic excursion with transthoracic echocardiography
Time frame: 1 hour
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 1 Sep 2023.
- Background: PubMed 21967480Ahmad H, Mor-Avi V, Lang RM, Nesser HJ, Weinert L, Tsang W, Steringer-Mascherbauer R, Niel J, Salgo IS, Sugeng L. Assessment of right ventricular function using echocardiographic speckle tracking of the tricuspid annular motion: comparison with cardiac magnetic resonance. Echocardiography. 2012;29(1):19-24. doi: 10.1111/j.1540-8175.2011.01519.x. Epub 2011 Oct 4.
- Background: PubMed 16376782Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. doi: 10.1016/j.echo.2005.10.005. No abstract available.
- Background: PubMed 20620859Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
- Background: PubMed 21338865Mor-Avi V, Lang RM, Badano LP, Belohlavek M, Cardim NM, Derumeaux G, Galderisi M, Marwick T, Nagueh SF, Sengupta PP, Sicari R, Smiseth OA, Smulevitz B, Takeuchi M, Thomas JD, Vannan M, Voigt JU, Zamorano JL. Current and evolving echocardiographic techniques for the quantitative evaluation of cardiac mechanics: ASE/EAE consensus statement on methodology and indications endorsed by the Japanese Society of Echocardiography. J Am Soc Echocardiogr. 2011 Mar;24(3):277-313. doi: 10.1016/j.echo.2011.01.015.
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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.
Nicholas W Markin, MD principal investigator
University of Nebraska
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 Ventricular Function, Right, run by University of Nebraska at 1 site in United States.
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 1 Sep 2023. 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 United States. 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?
Speckle-tracking derived tricuspid annular plane systolic excursion with transesophageal echocardiography (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01968252, which also lists 4 linked publications.
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 1 Sep 2023; AzTrials last refreshed its copy on 1 Nov 2026.