Echocardiography, 2-DTEENCT02854865
Specke Tracking Echocardiography And Filling Pressures
An observational study of Echocardiography, 2-D, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Determining the LV filling pressure is a key element in the diagnosis and management of patients with suspected decompensated heart failure. The aim of the present study is to assess whether a systolic 2D-STEderived parameter, global longitudinal peak systolic strain (GLPSS), acquired by transoesophageal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echocardiography, 2-D
- What is being tested?
- echocardiography
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2015to Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients schedulded for elective cardiac surgery
Who may be able to join
- patients scheduled for elective cardiac surgery
Who cannot join
- non-sinus rhythm
- severe mitral regurgitation
- mitral stenosis
- prosthetic mitral valve
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical university of vienna, General hospital of Vienna
Vienna, 1090
Ulrike Weber, M.D., +43 6766038002, ulrike.weber@meduniwien.ac.at
Ulrike Weber, M.D.
About this study
Official title: Feasibility of Speckle Tracking Echocardiography for Estimation of Left Ventricular Filling Pressures in Cardiac Surgery Patients: a Transoesophageal Study
Determining the LV filling pressure is a key element in the diagnosis and management of patients with suspected decompensated heart failure. The aim of the present study is to assess whether a systolic 2D-STEderived parameter, global longitudinal peak systolic strain (GLPSS), acquired by transoesophageal echocardiography (TEE) is superior to the E/Ea ratio in the estimation of the LVFP measured as the pulmonary capillary wedge pressure (PCWP) in patients during cardiac surgery. Automated function image (AFI) algorithm is a novel method based on 2D strain imaging that enables the simultaneous quantification of myocardial strain in different left ventricular segments; its 3-click method minimizes variability related to a manual training of endocardial border required in an usual 2D-strain analysis.
AFI provides GLPSS by averaging mid-oesophageal 4-, 2- chamber and long axis views. The study is a prospective observational single-center cohort study. 30 Patients scheduled for elective cardiac surgery will be included in the study group. The study is designed to assess whether GLPSS measured during cardiac surgery using AFI is superior to E/Ea ratio in estimation of LVFP measured as PCWP.
Read the detailed description
For normal cardiac performance, the left ventricle (LV) must be able to eject an adequate stroke volume at arterial pressure (systolic function) and fill without requiring an elevated left atrial (LA) pressure (diastolic function). These systolic and diastolic functions must be adequate to meet the needs of the body. Systolic function is conveniently (although not always accurately) measured as the ejection fraction (EF), calculated as stroke volume divided by end-diastolic volume. Diastolic function has been more difficult to evaluate and is characterized by changed left ventricular (LV) filling dynamics. The mean LA pressure is the source pressure for LV filling. Determining the LV filling pressure is a key element in the diagnosis and management of patients with suspected decompensated heart failure. Measurement of the pulmonary capillary wedge pressure (PCWP) with the Swan-Ganz catheter has become the gold standard for determining LV filling pressure. Invasively measured pulmonary capillary wedge pressure (PCWP) has been widely used as a surrogate for left ventricular filling pressure (LVFP) and is directly associated with functional capacity and prognosis in patients with heart failure. On the other hand, invasive procedures can produce complications, especially in critically ill patients and randomized clinical studies found no benefit from the use of the Swan-Ganz catheter to manage critically ill patients. Thus, efforts to find a noninvasive method of determining LV filling pressure have continued. One of the basic non-invasive parameters which reflect the LVFP is the ratio of peak early diastolic transmitral flow velocity (E) to peak early diastolic velocity of mitral annular motion (Ea) derived from conventional pulsed-wave and Doppler tissue echocardiography. The E/Ea ratio has been found to be superior to individual Doppler tissue imaging (DTI) parameters and to conventional pulsed-wave Doppler parameters assessing LV filling or pulmonary venous flow both in predicting the increase in LVFP and assessing of patient prognosis. However, DTI has inherent limitations which may have a negative impact on the accuracy of Ea measurements. Specifically, DTI is angle-dependent, and is affected by tethering, myocardial translation, and respiration motions. Recently, 2-dimensional speckle tracking echocardiography (2DSTE) has been introduced for the measurement of systolic and diastolic strain and strain rates (SRs) which does not have the above-mentioned limitations. Since most echocardiographic studies evaluating LVFP were performed with transthoracic echocardiography (TTE) in a cardiological setting and primarily diastolic 2D-STE parameters were described, the aim of the present study is to assess whether a systolic 2D-STEderived parameter, global longitudinal peak systolic strain (GLPSS), acquired by transoesophageal echocardiography (TEE) is superior to the E/Ea ratio in the estimation of the LVFP measured as the pulmonary capillary wedge pressure (PCWP) in patients during cardiac surgery. Automated function image (AFI) algorithm is a novel method based on 2D strain imaging that enables the simultaneous quantification of myocardial strain in different left ventricular segments; its 3-click method minimizes variability related to a manual training of endocardial border required in an usual 2D-strain analysis.
AFI provides GLPSS by averaging mid-oesophageal 4-, 2- chamber and long axis views. The study is a prospective observational single-center cohort study. Patients scheduled for elective cardiac surgery will be included in the study group. Written informed consent will be obtained from all patients before surgery. 30 consecutive patients scheduled for elective cardiac surgery who do not meet the exclusion criteria. The study is designed to assess whether GLPSS measured during cardiac surgery using AFI in 45 consecutive patients is superior to E/Ea ratio in estimation of LVFP measured as PCWP.
- Conditions
- Echocardiography, 2-D
- Being tested
- echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyOther
assess whether GLPSS measured during cardiac surgery using AFI is superior to E/Ea ratio in estimation of LVFP measured as PCWP
| Study group | Role | What they receive |
|---|---|---|
| Echocardiography | assess whether GLPSS measured during cardiac surgery using AFI is superior to E/Ea ratio in estimation of LVFP measured as PCWP Receives: Other: echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
global longitudinal peak systolic strain (GLPSS) acquired by transoesophageal echocardiography
postoperative offline measurement of strain
Measured: 30min after Induction of anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Echocardiography, 2-DStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrike Weber, Medical University of Vienna
- Investigators
- Ulrike Weber, M.D., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854865
- Sponsor's protocol ID
- 1791/2012
- Acronym
- TEE
- Status last verified
- Oct 2017
- First submitted
- 20 Jul 2016
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Speckle Tracking Echocardiography for Estimation of Left Ventricular Filling Pressures in Cardiac Surgery Patients: a Transoesophageal Study
- ClinicalTrials.gov ID
- NCT02854865
- Acronym / sponsor ID
- TEE / 1791/2012
- Conditions
- Echocardiography, 2-D
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 Aug 2016 (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.
Determining the LV filling pressure is a key element in the diagnosis and management of patients with suspected decompensated heart failure. The aim of the present study is to assess whether a systolic 2D-STEderived parameter, global longitudinal peak systolic strain (GLPSS), acquired by transoesophageal echocardiography (TEE) is superior to the E/Ea ratio in the estimation of the LVFP measured as the pulmonary capillary wedge pressure (PCWP) in patients during cardiac surgery. Automated function image (AFI) algorithm is a novel method based on 2D strain imaging that enables the simultaneous quantification of myocardial strain in different left ventricular segments; its 3-click method minimizes variability related to a manual training of endocardial border required in an usual 2D-strain analysis.
AFI provides GLPSS by averaging mid-oesophageal 4-, 2- chamber and long axis views. The study is a prospective observational single-center cohort study. 30 Patients scheduled for elective cardiac surgery will be included in the study group. The study is designed to assess whether GLPSS measured during cardiac surgery using AFI is superior to E/Ea ratio in estimation of LVFP measured as PCWP.
Detailed description
For normal cardiac performance, the left ventricle (LV) must be able to eject an adequate stroke volume at arterial pressure (systolic function) and fill without requiring an elevated left atrial (LA) pressure (diastolic function). These systolic and diastolic functions must be adequate to meet the needs of the body. Systolic function is conveniently (although not always accurately) measured as the ejection fraction (EF), calculated as stroke volume divided by end-diastolic volume. Diastolic function has been more difficult to evaluate and is characterized by changed left ventricular (LV) filling dynamics. The mean LA pressure is the source pressure for LV filling. Determining the LV filling pressure is a key element in the diagnosis and management of patients with suspected decompensated heart failure. Measurement of the pulmonary capillary wedge pressure (PCWP) with the Swan-Ganz catheter has become the gold standard for determining LV filling pressure. Invasively measured pulmonary capillary wedge pressure (PCWP) has been widely used as a surrogate for left ventricular filling pressure (LVFP) and is directly associated with functional capacity and prognosis in patients with heart failure. On the other hand, invasive procedures can produce complications, especially in critically ill patients and randomized clinical studies found no benefit from the use of the Swan-Ganz catheter to manage critically ill patients. Thus, efforts to find a noninvasive method of determining LV filling pressure have continued. One of the basic non-invasive parameters which reflect the LVFP is the ratio of peak early diastolic transmitral flow velocity (E) to peak early diastolic velocity of mitral annular motion (Ea) derived from conventional pulsed-wave and Doppler tissue echocardiography. The E/Ea ratio has been found to be superior to individual Doppler tissue imaging (DTI) parameters and to conventional pulsed-wave Doppler parameters assessing LV filling or pulmonary venous flow both in predicting the increase in LVFP and assessing of patient prognosis. However, DTI has inherent limitations which may have a negative impact on the accuracy of Ea measurements. Specifically, DTI is angle-dependent, and is affected by tethering, myocardial translation, and respiration motions. Recently, 2-dimensional speckle tracking echocardiography (2DSTE) has been introduced for the measurement of systolic and diastolic strain and strain rates (SRs) which does not have the above-mentioned limitations. Since most echocardiographic studies evaluating LVFP were performed with transthoracic echocardiography (TTE) in a cardiological setting and primarily diastolic 2D-STE parameters were described, the aim of the present study is to assess whether a systolic 2D-STEderived parameter, global longitudinal peak systolic strain (GLPSS), acquired by transoesophageal echocardiography (TEE) is superior to the E/Ea ratio in the estimation of the LVFP measured as the pulmonary capillary wedge pressure (PCWP) in patients during cardiac surgery. Automated function image (AFI) algorithm is a novel method based on 2D strain imaging that enables the simultaneous quantification of myocardial strain in different left ventricular segments; its 3-click method minimizes variability related to a manual training of endocardial border required in an usual 2D-strain analysis.
AFI provides GLPSS by averaging mid-oesophageal 4-, 2- chamber and long axis views. The study is a prospective observational single-center cohort study. Patients scheduled for elective cardiac surgery will be included in the study group. Written informed consent will be obtained from all patients before surgery. 30 consecutive patients scheduled for elective cardiac surgery who do not meet the exclusion criteria. The study is designed to assess whether GLPSS measured during cardiac surgery using AFI in 45 consecutive patients is superior to E/Ea ratio in estimation of LVFP measured as PCWP.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echocardiography | – | Other: echocardiographyassess whether GLPSS measured during cardiac surgery using AFI is superior to E/Ea ratio in estimation of LVFP measured as PCWP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients schedulded for elective cardiac surgery
Key inclusion criteria (1 listed)
- patients scheduled for elective cardiac surgery
Key exclusion criteria (4 listed)
- non-sinus rhythm
- severe mitral regurgitation
- mitral stenosis
- prosthetic mitral valve
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiographyassess whether GLPSS measured during cardiac surgery using AFI is superior to E/Ea ratio in estimation of LVFP measured as PCWP | Other | Echocardiography |
Primary outcome
global longitudinal peak systolic strain (GLPSS) acquired by transoesophageal echocardiography
Time frame: 30min after Induction of anaesthesia
postoperative offline measurement of strain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Individual participant dataSharing planned: No
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.
Medical university of vienna, General hospital of Vienna
Vienna, Austria
Ulrike Weber, M.D. principal investigator
Medical University of Vienna
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 Echocardiography, 2-D, 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 1 inclusion and 4 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 20 Oct 2017. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
global longitudinal peak systolic strain (GLPSS) acquired by transoesophageal echocardiography (time frame: 30min after Induction of anaesthesia). 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 20 Oct 2017.