- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00877565
Global Longitudinal Peak Systolic Strain (GLPSS) Derived From Transesophageal Echocardiography - A Reliable Measure of Systolic Function? (2DSonTOEcho)
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
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).
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Vienna, Austria, 1090
- Recruiting
- Clin. Dept. of Cardiothoracic and Vascular Anaesthesia and Intensive Medicine, Medical University of Vienna
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Principal Investigator:
- Heinz D Tschernich, M.D.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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multivariate regression-analysis
Time Frame: 1, 5 years
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1, 5 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VI_echo_01_2009
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