Global Longitudinal Peak Systolic Strain (GLPSS) Derived From Transesophageal Echocardiography - A Reliable Measure of Systolic Function?

Surgery Clinical Trial

— 2DSonTOEcho  

Official title:

Is Global Longitudinal Peak Systolic Strain (GLPSS) Derived From Transesophageal Echocardiography a Reliable Measure of Systolic Function? A Multicenter-Study to Compare GLPSS With Ejection Fraction Derived From Biplane Simpson´s Method on TTE and TEE in Patients Undergoing Elective Cardiac and Non-Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00877565
• Other study ID #: VI_echo_01_2009
• Status: Recruiting
• Phase: Phase 4
• First received: April 7, 2009
• Last updated: April 7, 2009
• Start date: February 2009

Study information

• Verified date: April 2009
• Source: Medical University of Vienna
• Contact: Heinz D Tschernich, M.D.
• Phone: +43140400
• Email: heinz.tschernich[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Ethics Committee of the Medical University of Vienna
• Study type: Observational

Clinical Trial Summary

Systolic function is a substantial determinant of overall hemodynamics and organ function.

Therefore assessment of left ventricular systolic function (LVF) has been of central interest in Echocardiography. Ejection fraction (EF) measurement has been the gold standard echo-derived measure to describe LVF. However, EF is a blood pool derived and therefore load dependent measure.

Global longitudinal peak systolic strain average is a new parameter derived from speckle tracking tachnique. As a primarily myocardial deformation parameter it is considered to be an equivalent to EF measurement, but maybe less load dependend. The aim of the study is to investigate the reliability of GLPSS average to quantify LVF in the perioperative setting (in cardiac and non-cardiac cases).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 90 Years

Eligibility

Inclusion Criteria:

• Adult patients in the age from 19-90 years

• Cardiac and non-cardiac surgery, where intubation is indicated

• Surgical procedures with a minimum duration of 30 min

• Elective cardiac surgery on patients scheduled for correction of:

• coronary artery disease with and without previous myocardial infarction

• dilated cardiomyopathy; HOCM

• disorders of the atrial or ventricular septum

• disorders of the aortic root or the aorta

• left and right heart valvular disease including stenotic and/or regurgitant valvular diseases.

Exclusion Criteria:

• No patient´s consent

• Contraindications for TEE (esophageal-, gastric disorders, haematologic disorders with increased bleeding incidence; ENT-surgery, surgery of the esophageus or stomach)

• Contraindications for positioning (e.g. clinical signs of acute lung edema/acute failing left or right heart, acute coronary syndrome, myocardial infarction in recent history = within 2 weeks prior to operation date)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Surgery

Locations

Country	Name	City	State
Austria	Clin. Dept. of Cardiothoracic and Vascular Anaesthesia and Intensive Medicine, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	multivariate regression-analysis		1, 5 years	No