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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • 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.

    Recruiting

Other trials in Austria

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.

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 groups in NCT02854865
Study groupRoleWhat they receive
Echocardiographyassess 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.

  1. 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.

  1. First posted4 Aug 2016 (estimated)
  2. Study startJan 2015
  3. Primary completionJun 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

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)
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

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.

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