Surgery2DSonTOEchoNCT00877565
Global Longitudinal Peak Systolic Strain (GLPSS) Derived From Transesophageal Echocardiography - A Reliable Measure of Systolic Function?
An observational study of Surgery, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Surgery
- How many people
- 400 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac and non-cardiac surgery
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Clin. Dept. of Cardiothoracic and Vascular Anaesthesia and Intensive Medicine, Medical University of Vienna
Vienna, 1090
Heinz D Tschernich, M.D.
About this study
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
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).
- Conditions
- Surgery
- Keywords
- LVF, Left ventricular systolic function
What is being measured
The primary outcome is the main question the study is designed to answer.
multivariate regression-analysis
Measured: 1, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877565
- Sponsor's protocol ID
- VI_echo_01_2009
- Acronym
- 2DSonTOEcho
- Status last verified
- Apr 2009
- First submitted
- 7 Apr 2009
- Last updated
- 8 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00877565
- Acronym / sponsor ID
- 2DSonTOEcho / VI_echo_01_2009
- Conditions
- Surgery
- Keywords
- LVF, Left ventricular systolic function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Feb 2009
- First posted
- 8 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac and non-cardiac surgery
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
multivariate regression-analysis
Time frame: 1, 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heinz D Tschernich, M.D. (+43140400 ext. 4109, heinz.tschernich@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
multivariate regression-analysis (time frame: 1, 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2009.