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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04490538
Other study ID # 284/34
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 27, 2020
Est. completion date October 31, 2020

Study information

Verified date August 2020
Source Emergency Medical Service of the Central Bohemian Region, Czech Republic
Contact Roman Skulec, MD, PhD
Phone 00420777577497
Email skulec@email.cz
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 31, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Transthoracic echocardiography
Conventional transthoracic echocardiographic examination at the intensive care unit.

Locations

Country Name City State
Czechia Masaryk Hospital Usti nad Labem Usti nad Labem

Sponsors (2)

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

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Validity of sTAPSE in prediction of right ventricular systolic dysfunction sTAPSE is a new potential echocardiographic parameter of right ventricular systolic function measurable from subcostal view. During the intervention
Secondary Correlation of sTAPSE with conventional TAPSE sTAPSE is a new potential echocardiographic parameter of right ventricular systolic function measurable from subcostal view. During the intervention
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