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Echocardiography, DopplerNCT03088943

Intraoperative Diastolic Function by TDI and STE

A study testing TTE Apical 4 Chamber View, TEE dTG View and TEE ME 4C View in people with Echocardiography, Doppler and Echocardiography, Three-Dimensional, run by Patrick F Wouters, MD PhD at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project aims at exploring measures of diastolic function perioperatively. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TTE Apical 4 Chamber View, TEE dTG View and TEE ME 4C View
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteBelgium
Study dates
14 Feb 2017to 15 Jan 2018
Phase
Interventional
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

  • ≥18 years
  • undergoing cardiac surgery, and
  • routinely receiving TEE for the surgical procedure, independent of the study.

Who cannot join

  • atrial flutter or fibrillation
  • severe mitral calcification
  • cancelled surgery
  • unwilling or unable to provide consent

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Ghent University Hospital

    Ghent, East-Flanderse, 9000

Other trials in Belgium

About this study

Official title: Assessment of Diastolic Function Using Intraoperative Transesophageal Echocardiography: Comparison of Mitral Annular Plane Velocity and Systolic Excursion Measured by Tissue Doppler Imaging vs. Speckle-Tracking

This project aims at exploring measures of diastolic function perioperatively.

Read the detailed description

Perioperative echocardiographic quantification of myocardial function is of great importance in patient management and is increasingly being recommended intraoperatively in spite of some unresolved or under-explored issues. One such issue is the perioperative measurement of diastolic function. Diastolic dysfunction and diastolic heart failure - or as commonly referred to "heart failure with preserved ejection fraction (HFpEF)" - is responsible for some 35 to 50% of heart failures. Intraoperative measurements of diastolic function have a prognostic and management relevance for patients undergoing both cardiac and non-cardiac surgery. However, even recent guidelines on intraoperative transesophageal echocardiography (TEE) have neglected this topic, with the exception of the most recent, which briefly alluded to the role TEE can play in assessing diastolic function, but without addressing the issue of which measurements or views to use.

The clinically prevalent echocardiographic view for assessment of intraoperative diastolic function by tissue Doppler imaging (TDI) is the midesophageal 4-chamber (ME 4C) TEE view. This view, which looks at the heart from the left atrium, is the standard view for evaluating intraoperative global cardiac performance. However, the Doppler angle for assessing diastolic performance is generally much greater than 20° and, as Doppler techniques are known to be angle dependent based on the Doppler equation, using this view may relevantly underestimate TDI velocities. Views from the apex of the heart (i.e. both the deep transgastric long axis view [dTG LAX] TEE view as well as the apical 4-chamber [AP 4C] transthoracic echocardiography (TTE) view) have a cosine angle towards the mitral annular plane excursion near zero, thereby allowing valid measurements according to the Doppler equation. However, TDI velocities are often - and potentially erroneously - reported from the ME 4C TEE view.

The objective of this project is to address a number of important clinical topics regarding diastolic dysfunction in TEE.

Two main objectives will be examined:

  • Assess whether or not tissue doppler imaging (TDI) measurements of mitral annular plane velocities and systolic excursion in the midesophageal 4-chamber TEE view (ME 4C) significantly underestimate diastolic cardiac performance compared to the deep transgastric long axis TEE view (dTG LAX) due to intrinsic misalignment of the doppler beam. [i.e. is there a technological limitation?]
  • Assess whether or not the difference in mitral annular plane velocities and systolic excursion between the ME 4C and dTG LAX will be underestimated using TDI compared to values derived from speckle tracking echocardiography (STE). [i.e. if there is a technological limitation, does STE show more consistency?]

Two secondary objectives will be examined:

  • Determine the influence of frame rates (temporospatial resolution) on STE-derived mitral annular velocities and systolic excursion by conducting STE measurement post cardiopulmonary Bypass (CPB) in atrially paced patients in the 1. midesophageal 4 chamber view (ME 4C) and 2. deep transgastric long axis view (dTG LAX). [i.e. if ST shows more consistency, what are its limitations?]
  • Confirm the existence of and explore potential reasons (anesthesia, ventilation, TTE vs. TEE, Doppler alignment) for differences in mitral annular plane velocities and systolic excursion observed preoperatively (i.e. by cardiologists) and intraoperatively (i.e. by anesthetists, intensivists). Specifically, we will compare these values in four views: 1. apical 4-chamber view in TTE (AP 4C) preinduction, 2. apical 4-chamber view in TTE (AP 4C) postinduction, 3. midesophageal 4 chamber view (ME 4C) postinduction, and 4. Deep transgastric long axis view (dTG LAX) postinduction. [i.e. what is the relative contribution of the ignoring the misalignment in angulation compared to other intraoperative factors in explaining the observed underestimation of diastolic velocities and distances seen by cardiologists (AP 4C TTE view) and anesthetist's/intensivist's (ME 4C TEE view)?]
Being tested
TTE Apical 4 Chamber View, TEE dTG View, TEE ME 4C View

What participants receive

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

  • TTE Apical 4 Chamber ViewOther

    We will measure a number of echocardiography parameters by TTE (apical 4 Chamber View) prior to and after induction

  • TEE dTG ViewOther

    We will measure a number of echocardiography parameters by TEE (dTG View) prior to cardiopulmonary bypass and after cardiopulmonary bypass (atrially paced at 80, 100, and 120 bpm)

  • TEE ME 4C ViewOther

    We will measure a number of echocardiography parameters by TEE (ME 4C View) prior to cardiopulmonary bypass and after cardiopulmonary bypass (atrially paced at 80, 100, and 120 bpm)

Study groups in NCT03088943
Study groupRoleWhat they receive
TTE Apical 4 Chamber ViewOtherPatients will receive TTE apical 4chamber echo examinations prior to induction and after induction
Receives: Other: TTE Apical 4 Chamber View
TEE dTG ViewOtherPatients will receive TEE deep transgastric echo examinations after induction and after cardiopulmonary bypass induction (paced at 80, 100, and 120 bpm)
Receives: Other: TEE dTG View
TEE ME 4C ViewOtherPatients will receive TEE midesophageal 4chamber echo examinations after induction and after cardiopulmonary bypass induction (paced at 80, 100, and 120 bpm)
Receives: Other: TEE ME 4C View

What is being measured

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

  1. mean early diastolic mitral annular plane velocity (E')

    (E'lateral + E'medial)/2; by TDI and STE

    Measured: immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view)

Secondary outcomes (10)
  1. mean late (atrial) diastolic mitral annular plane velocity (A')

    (A'lateral + A'medial)/2; by TDI and STE

    Measured: immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view)

  2. mean early diastolic mitral annular plane velocity/mean late (atrial) diastolic mitral annular plane velocity (E'/A')

    [(E'lateral + E'medial)/2] / [(A'lateral + A'medial)/2]; by TDI and STE

    Measured: immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view)

  3. mean early diastolic mitral inflow velocity/mean early diastolic mitral annular plane velocities; (E/E')

    E/[(E'lateral + E'medial)/2]; by doppler, TDI, and STE

    Measured: immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view)

  4. Peak systolic mitral annular velocity (S')

    by TDI and STE

    Measured: immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view)

  5. Displacement by Mitral Annular Plane Systolic Excursion (MAPSE)

    (MAPSEmedial + MAPSElateral)/2

    Measured: immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view)

  6. Displacement by Tricuspid Annular Place Systolic Excursion (TAPSE)

    only laterally

    Measured: immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view)

  7. Displacement of Mitral Annular Plane (by speckle-tracking software)

    using tissue Motion annular displacement (TMAD) in Cardiovascular Ultrasound Quantification Software (QLAB)

    Measured: immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view)

  8. Displacement of Tricuspid Annular Plane (by speckle-tracking software)

    using tissue Motion annular displacement (TMAD) in Cardiovascular Ultrasound Quantification Software (QLAB)

    Measured: immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view)

  9. 3D volumes of left ventricle

    using 4-beat ECG-gated image acquisition

    Measured: immediately during echo exam while in the operating room; i.e. postinduction (TEE ME 4C view), post-CPB (TEE ME 4C view)

  10. 3D volumes of right ventricle

    using 4-beat ECG-gated image acquisition

    Measured: immediately during echo exam while in the operating room; i.e. postinduction (TEE ME 4C view), post-CPB (TEE ME 4C view)

Timeline

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

  1. First posted24 Mar 2017
  2. Study start14 Feb 2017
  3. Primary completion15 Jan 2018
  4. Study completion15 Jan 2018

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 N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Patients will receive a series of perioperative echocardiographical measurements by TTE as well as TEE prior to induction, postinduction, and post cardiopulmonary bypass
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03088943
Sponsor's protocol ID
2016/1550
Status last verified
Jan 2018
First submitted
14 Feb 2017
Last updated
7 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: undecided

Publications

  • Mauermann E, Bouchez S, Bove T, Vandenheuvel M, Wouters P. Assessing Left Ventricular Early Diastolic Velocities With Tissue Doppler and Speckle Tracking by Transesophageal and Transthoracic Echocardiography. Anesth Analg. 2021 May 1;132(5):1400-1409. doi: 10.1213/ANE.0000000000005469.

    PubMed 33857980

Questions about this trial

What is this clinical trial studying?

A study testing TTE Apical 4 Chamber View, TEE dTG View and TEE ME 4C View in people with Echocardiography, Doppler and Echocardiography, Three-Dimensional, run by Patrick F Wouters, MD PhD at 1 site in Belgium.

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 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: finished, as of the sponsor's last update on 7 Dec 2022. 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 Belgium. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mean early diastolic mitral annular plane velocity (E') (time frame: immediately during echo exam while in the operating room; i.e. preinduction (TTE AP 4C), postinduction (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view), post-CPB (TTE AP 4C view, TEE ME 4C view, TEE dTG LAX view)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03088943, which also lists 1 linked publication.

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 7 Dec 2022.

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