Global Longitudinal Peak Systolic Strain (GLPSS) Derived From Transesophageal Echocardiography - A Reliable Measure of Systolic Function? (2DSonTOEcho)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00877565
First received: April 7, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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).


Condition Phase
Surgery
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • multivariate regression-analysis [ Time Frame: 1, 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: February 2009
  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing cardiac and non-cardiac surgery

Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00877565

Contacts
Contact: Heinz D Tschernich, M.D. +43140400 ext 4109 heinz.tschernich@meduniwien.ac.at

Locations
Austria
Clin. Dept. of Cardiothoracic and Vascular Anaesthesia and Intensive Medicine, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Principal Investigator: Heinz D Tschernich, M.D.         
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Heinz D. Tschernich, Clin. Dept. of Cardiothoracic and Vascular Anaesthesia & Intensive Medicine, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00877565     History of Changes
Other Study ID Numbers: VI_echo_01_2009
Study First Received: April 7, 2009
Last Updated: April 7, 2009
Health Authority: Austria: Ethics Committee of the Medical University of Vienna

Keywords provided by Medical University of Vienna:
LVF
Left ventricular systolic function

ClinicalTrials.gov processed this record on July 23, 2014