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Ventricular Function, LeftPhase 4StrainNCT01080495

Evaluation of Radial Strain for Assessment of Left Ventricular Function in Transesophageal Echocardiography

A Phase 4 study testing TEE (transesophageal echocardiography) in people with Ventricular Function, Left, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Assessment of left ventricular function is an essential determinant of overall hemodynamics and heart function and therefore of central interest in intra-operative transesophageal echocardiography. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ventricular Function, Left
What is being tested?
TEE (transesophageal echocardiography)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteAustria
Study dates
Feb 2010to Dec 2010
Phase
Phase 4
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

Who may be able to join

  • Planned non-cardiac surgery with a minimum duration of 60 minutes, where intubation is indicated
  • Age above 18 years
  • Signed informed consent

Who cannot join

  • No patient's consent
  • Subjects not able to understand study procedures
  • Contraindications to transesophageal echocardiography (oesophageal-, gastric disorders, hematologic disorders with increased bleeding incidence, ENT-surgery, surgery of the oesophagus or stomach)
  • Medical history of any kind of heart disease, dyspnea or angina pectoris
  • Hypertension (medically treated)
  • Diabetes
  • Atrial fibrillation

Trial locations and contacts

1 site in 1 country.

Austria1 site, 1 recruiting
  • University Hospital of Vienna

    Vienna, State of Vienna, 1090

    Ulrike Weber, M.D., 0043 1404004109, ulrike.weber@meduniwien.ac.at

    Ulrike Weber, M.D.

    Recruiting

Other trials in Austria

About this study

Official title: Evaluation of Radial Strain Versus Fractional Shortening and Fractional Area Change for Assessment of Left Ventricular Function in Transesophageal Echocardiography

Assessment of left ventricular function is an essential determinant of overall hemodynamics and heart function and therefore of central interest in intra-operative transesophageal echocardiography.

Currently, the most frequently used methods for quantification of left ventricular function are fractional shortening (FS) and fractional area change (FAC).

Radial strain is a new parameter to asses left ventricular function. The investigators want to assess left ventricular function with radial strain, fractional shortening (FS) and fractional area change (FAC) in non-cardiac patients during non-cardiac operations. The aim of this study is to show that radial strain is as reliable as FS and FAC in left ventricular function assessment and more robust to changes in preload and afterload conditions.

Read the detailed description

Assessment of left ventricular function is an essential determinant of overall hemodynamics and heart function and therefore of central interest in intra-operative transesophageal echocardiography.

Currently, the most frequently used methods for quantification of left ventricular function are fractional shortening (FS) and fractional area change (FAC). These parameters can be assessed in the transgastric mid papillary short axis view (TG SAX) to quantify left ventricular systolic function. Limitations of these methods are the experience of the investigator - the more experienced the investigator the more reliable and reproducible the data are, load dependency of these methods and the geometrical assumption of a one-dimensional measurement for assessment of a three-dimensional contracting left ventricle. Therefore, LV-function will either be over- or underestimated by influence of segmental wall motion abnormalities or by missing them.

Radial strain allows reliable and reproducible evaluation of left ventricular function and also allows assessment of myocardial deformation from representative segments of each wall of the left ventricle. Myocardial strain is described as the relative deformation of a myocardial fiber, normalized to its original length:L1-L0/L0(%). Strain is positive (radial thickening) if L1>L0 and negative (longitudinal shortening and circumferential thinning) if L1<L0. Radial strain is sensitive to changes in contractility and less influenced by loading conditions which occur frequently during anaesthesia in a wide spectrum of non-cardiac surgery as a result of blood loss or loss of hemodynamic autoregulation due to anesthetic drugs.

Therefore we want to assess left ventricular function with radial strain, fractional shortening (FS) and fractional area change (FAC) in non-cardiac patients during non-cardiac operations. The aim of this study is to show that radial strain is as reliable as FS and FAC in left ventricular function assessment and more robust to changes in preload and afterload conditions.

Study hypothesis

The aim of the study is to compare fractional shortening (FS) and fractional area change (FAC) with radial strain from TG mid SAX using TEE in the anaesthetized patient undergoing non-cardiac surgery. Furthermore we want to investigate the influence of changes in loading conditions on these parameters in the anaesthetized non-cardiac patient undergoing non-cardiac surgery. Therefore patients are examined in zero position, trendelenburg- and anti-trendelenburg-position.

Hypothesis:

  • Radial strain correlates with FAC and FS in assessment of left ventricular function in patients undergoing non-cardiac surgery. FAC is of primary interest because it has several advantages: it is very easy to calculate, it´s considered a surrogate of ejection fraction, and several studies have shown that it is an excellent measure of left ventricular function even in patients with heterogeneity of regional function.
  • The parameters radial strain, fractional shortening and fractional area change correlate during are changes in loading conditions (zero-position, trendelenburg- and anti-trendelenburg-maneuver).

Study design: prospective cohort study Inclusion criteria

  • Planned non-cardiac surgery with a minimum duration of 60 minutes, where intubation is indicated
  • Age above 18 years
  • Signed informed consent Exclusion criteria
  • No patient's consent
  • Subjects not able to understand study procedures
  • Contraindications to transesophageal echocardiography (oesophageal-, gastric disorders, hematologic disorders with increased bleeding incidence, ENT-surgery, surgery of the oesophagus or stomach)
  • Medical history of any kind of heart disease, dyspnea or angina pectoris
  • Hypertension (medically treated)
  • Diabetes
  • Atrial fibrillation Study protocol One day prior to surgery the patients are screened and invited to participate in the study by the principle investigator. If they consent the principle investigator does a physical examination and takes their medical history.

On the day of surgery patients receive premedication as usual. Arriving at the operating room the patients are monitored with ECG, pulse oximetry and blood pressure (either invasive with insertion of an arterial catheter, when indicated, or non-invasive blood pressure). A peripheral venous line is needed for induction of anaesthesia. Induction and maintenance of anaesthesia is performed using standard protocols. After induction of anaesthesia and insertion of all needed catheters (central venous catheter, bladder catheter, arterial catheter, and eventually pulmonary artery catheter) the transoesophageal probe, covered with a special condom, will be inserted.

The examination will be done by the principle investigator (Dr. Ulrike Weber) under supervision of an expierenced investigator.

Intraoperative TEE-Examinations (T1, T2, T3)

At T1, T2, T3 TEE-study examinations are performed in zero position, Trendelenburg position, and anti-Trendelenburg position. Positioning will follow a random order according to a blinded randomization list.

Trendelenburg-position shall be defined for the study with 10cm head-down from horizontal position, anti-trendelenburg position with 10cm head-up (from horizontal position). After positioning examination will start after a 3 min delay for reaching a steady-state in loading conditions.

T1 - after induction of anesthesia

After insertion of the probe a transesophageal echo examination (TEE) is performed - including a complete routine clinical examination (T1):

T2 - Intraoperative TEE, 3min after positioning

Positioning (zero position, Trendelenburg, anti-trendelenburg) will be performed according to randomization. 3min after positioning, under stable hemodynamics, recordings of HR, blood pressure, FS, FAC, Radial strain

T3 - Intraoperative TEE, 3min after positioning

Positioning (zero position, Trendelenburg, anti-trendelenburg) will be performed according to randomization. 3min after positioning, under stable hemodynamics, recordings of HR, blood pressure, FS, FAC, Radial strain

The following measurements are taken for the study (3 times during sinus rhythm):

  • FS in the transgastric short axis mid papillary view
  • FAC in the transgastric short axis mid papillary view
  • Radial strain in the transgastric short axis mid papillary view

Recordings of the 2D-mode images of the TG SAX shall be taken in triplicate with 3 heart cycles per stored clip. The images will be stored digitally in the EchoPAC-raw data format.

Analysis of data will be performed offline in a dedicated work station (EchoPAC, GE Vingmed, Horten, Norway). Three different investigators will analyse all data two times at two different time points.

Expected study population: 33 patients

Being tested
TEE (transesophageal echocardiography)
Keywords
left ventricular function, radial strain, fractional shortening, fractional area change
Medical subject headings
Sprains and Strains

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEE (transesophageal echocardiography)Procedure or surgery

    Also called radial strain

    a TEE is performed in all study objects and all parameters (radial strain, fractional shortening and fractional area change) are analysed

Study groups in NCT01080495
Study groupRoleWhat they receive
TEE (transesophageal echcardiography)Otherall patients get TEE and all parameters (radial strain, fractional shortening and fractional area change) are evaluated
Receives: Procedure: TEE (transesophageal echocardiography)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. left ventricular function

    for left ventricular function transgastric short axis view is recorded 3 times for 3 heart cycles in 3 different positions (zero-position, trendelenburg- and antitrendelenburg-position)

    Measured: 3min during TEE

Secondary outcomes (1)
  1. left ventricular function during changes in loading conditions

    for left ventricular function transgastric short axis view is recorded 3 times for 3 heart cycles in 3 different positions (zero-position, trendelenburg- and antitrendelenburg-position)

    Measured: 3min during TEE

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionDec 2010 (estimated)
  4. Study completionDec 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01080495
Sponsor's protocol ID
787/2009
Acronym
Strain
Status last verified
Feb 2010
First submitted
11 Feb 2010
Last updated
4 Mar 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TEE (transesophageal echocardiography) in people with Ventricular Function, Left, 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 3 inclusion and 7 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 4 Mar 2010. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Ulrike Weber, M. D. (+43 40400 4109, ulrike.weber@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

left ventricular function (time frame: 3min during TEE). 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 4 Mar 2010.

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