Evaluation of Right Ventricular Systolic Function by TAPSE Parameter From Subcostal View

• Sponsor: Emergency Medical Service of the Central Bohemian Region, Czech Republic (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04490538
• Collaborator: Masaryk Hospital Usti nad Labem (Other)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 3.2
• Patients Per Site Per Month: 31.7

Study Details

Study Description

Brief Summary

The purpose of this study is to validate a new echocardiographic parameter evaluating right ventricular function.

Condition or Disease	Intervention/Treatment	Phase
Transthoracic Echocardiography	Diagnostic Test: Transthoracic echocardiography

Detailed Description

The key conventional echocardiographic parameter evaluating right ventricular systolic function is the tricuspid annular plane systolic excursion (TAPSE). It is measured in apical four chamber view by conventional M-mode imaging. Other echocardiographic parameters of right ventricular systolic function (Fractional Area Change; Tricuspid Lateral Annular Systolic Velocity; Right Ventricular Index of Myocardial Performance) are evaluated in apical four chamber view as well. However, this view might not be clearly visible in the clinical setting of critical illness and subcostal view is often preferred for its higher quality. Unfortunately, conventional M-mode can not be used for measurement in this view but anatomical M-mode imaging can. Therefore, the investigators decided to evaluate whether TAPSE measured in subcostal view by anatomical M-mode (sTAPSE) correlates with conventional TAPSE and whether reliably reflects systolic right ventricular function.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Echocardiographic Evaluation of Right Ventricular Systolic Function by TAPSE Parameter Measured From Subcostal View Using Anatomical M-mode - Validation Clinical Study
• Actual Study Start Date: Jul 27, 2020
• Anticipated Primary Completion Date: Sep 30, 2020
• Anticipated Study Completion Date: Oct 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Critically ill patients Critically ill patients hospitalised at the intensive care unit indicated to echocardiographic examination.	Diagnostic Test: Transthoracic echocardiography; Conventional transthoracic echocardiographic examination at the intensive care unit.

Outcome Measures

Primary Outcome Measures

1. Validity of sTAPSE in prediction of right ventricular systolic dysfunction [During the intervention]

   sTAPSE is a new potential echocardiographic parameter of right ventricular systolic function measurable from subcostal view.

Secondary Outcome Measures

1. Correlation of sTAPSE with conventional TAPSE [During the intervention]

   sTAPSE is a new potential echocardiographic parameter of right ventricular systolic function measurable from subcostal view.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Inpatients

• All patients hospitalised in intensive care unit indicated for transthoracic echocardiography examination

Exclusion Criteria:

• Age <18 years

• Insufficient imaging quality of transthoracic echocardiography

• Refusal of echocardiographic examination by patient

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masaryk Hospital Usti nad Labem	Usti nad Labem		Czechia	40113

Sponsors and Collaborators

• Emergency Medical Service of the Central Bohemian Region, Czech Republic
• Masaryk Hospital Usti nad Labem

Investigators

• Principal Investigator: Roman Skulec, MD, PhD, Masaryk Hospital Usti nad Labem

Study Documents (Full-Text)

None provided.

More Information

Publications

• Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2015 Mar;16(3):233-70. doi: 10.1093/ehjci/jev014. Review. Erratum in: Eur Heart J Cardiovasc Imaging. 2016 Apr;17(4):412. Eur Heart J Cardiovasc Imaging. 2016 Sep;17 (9):969.

• Responsible Party: Roman Skulec, Principal investigator, Masaryk Hospital Usti nad Labem
• ClinicalTrials.gov Identifier: NCT04490538
• Other Study ID Numbers: 284/34
• First Posted: Jul 29, 2020
• Last Update Posted: Aug 19, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Systolic Murmurs

Study Results

No Results Posted as of Aug 19, 2020