Speckle-tracking Tricuspid Annular Plane Systolic Excursion

Ventricular Function, Right Clinical Trial

Official title:

Validation of Speckle-tracking Echocardiography Measurements of Tricuspid Annular Plane Systolic Excursion During Transesophageal Echocardiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968252
• Other study ID #: 0107-14-EP
• Status: Completed
• Start date: May 1, 2014
• Est. completion date: November 1, 2015

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Description:

1. Use of speckle-tracking echocardiography to validate tricuspid annular plane systolic excursion measurements with transesophageal echocardiography. 2. 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. 3. All subjects undergoing a planned surgical procedure in which the use of transesophageal echocardiography would be used regardless for their management. 4. No interventions, only evaluation of the measurements obtained with transthoracic echocardiography compared to transesophageal echocardiography. 5. No follow-up, study will be completed at the time of image acquisition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: November 1, 2015
• Est. primary completion date: February 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

Inclusion Criteria:

• All subjects who are scheduled to undergo general anesthesia and concurrently will be managed with intraoperative transesophageal echocardiography will be included in potential subjects.

Exclusion Criteria:

• Subjects who do not have adequate transesophageal and/or transthoracic imaging windows to allow for accurate analysis of tricuspid annular motion.

Related Conditions & MeSH terms

• Systolic Murmurs
• Ventricular Function, Right

Intervention

Other:
• Concurrent TTE and TEE
All subjects will undergo both transthoracic echocardiography and transesophageal echocardiography to compare the results of measurements obtained from both imaging locations.

Locations

Country	Name	City	State
United States	Unversity of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Lang 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. — View Citation

Mor-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. — View Citation

Rudski 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speckle-tracking derived tricuspid annular plane systolic excursion with transesophageal echocardiography	Speckle-tracking derived tricuspid annular plane systolic excursion with transesophageal echocardiography	1 hour
Secondary	M-mode derived tricuspid annular plane systolic excursion with transesophageal echocardiography	M-mode derived tricuspid annular plane systolic excursion with transesophageal echocardiography	1 hour
Secondary	M-mode derived tricuspid annular plane systolic excursion with transthoracic echocardiography	M-mode derived tricuspid annular plane systolic excursion with transthoracic echocardiography	1 hour
Secondary	Speckle-tracking derived tricuspid annular plane systolic excursion with transthoracic echocardiography	Speckle-tracking derived tricuspid annular plane systolic excursion with transthoracic echocardiography	1 hour