Intraoperative Global Longitudinal Strain and Global Longitudinal Strain Rate as Predictors of Unfavorable Outcome in On-Pump Mitral Surgery (Mit-GO)

May 3, 2026 updated by: Fabrizio Monaco, Scientific Institute San Raffaele

Intraoperative Transesophageal Echocardiography in On-pump Mitral Surgery: A Single Center Prospective Observational Study of Global Longitudinal Strain and Global Longitudinal Strain Rate as Predictors of Unfavorable Outcome

The aim of the present study is to assess the best echocardiographic parameters (GLS, GLS rate and standard echocardiographic parameters) predicting LCOS in on-pump mitral surgery.

Study Overview

Detailed Description

Low cardiac output syndrome (LCOS) is a common complication in cardiac surgery after weaning from cardiopulmonary bypass (CPB) associated with high morbidity and mortality. Its prompt recognition and management may mitigate the effect of LCOS on the outcome. To date, advanced age, prolonged CPB, urgent surgery and impaired left ventricular function assessed by left ventricular ejection fraction (LVEF) are commonly considered strong predictors of postoperative LCOS. Nevertheless, LVEF has several limitations including image quality, operator experience, limited reproducibility, inter- and intra-observer discrepancy and load/volume dependency. Global Longitudinal Strain (GLS), with automated speckle-tracking echocardiography (STE) may overcome several of the LVEF limitations. In fact, while the LVEF detects changes in left ventricular chamber volume, GLS reflects myocardial longitudinal deformation due to contraction. The rate of myocardial deformation over time (expressed as 1/s) is called GLS Rate. Global Longitudinal Strain, mostly evaluated from transthoracic echocardiography (TTE), has shown lower inter- and intra-observer variability, a better reproducibility and prognostic value compared to LVEF in a generic cardiac population. In addition the results of the GLS with TTE (GLS-TTE) may not be shifted in cardiac surgery due to the effect of the general anesthesia (GA) and positive pressure ventilation. Thus, these factors should be considered when the global longitudinal strain, evaluated from transesophageal echocardiography (GLS-TEE) is used as predictor of early outcome. Amabili et al. have shown that GLS-TEE is better than LVEF in predicting LCOS in a general cardiac surgery population. Similarly Sonny et al. in patients undergoing aortic valve surgery for stenosis have reported that a GLS-TEE and GLS-TEE Rate are superior to standard echocardiographic parameters in predicting a complicated course. To the best of our knowledge, there are no studies investigating the role of intraoperative evaluation of GLS-TEE and GLS-TEE Rate as predictors of LCOS in mitral valve surgery. In this setting LVEF is not a reliable marker of cardiac function due to a systematic overestimation of the ejection fraction. Moreover these patients are at high risk of postoperative cardiac dysfunction and LCOS owing to the afterload mismatch after mitral surgery. For the reasons mentioned above, more effective predictors are advocated. In the present study we try to fill the gap. Thus, aim of present study is to assess the role of GLS-TEE, GLS-TEE Rate and standard echocardiographic parameters in predicting LCOS in on-pump mitral surgery. In doing so, the best cut-off for each echocardiographic parameter will be provided. Finally to detect the effect of the GA, the echocardiographic parameters calculated after the induction of GA will be compared with those collected preoperatively.

A telephonic follow-up will be performed at 30 days and 12-months investigating mortality and rehospitalization due to heart failure.

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Milan, Italy, 20132
        • Scientific Institute San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing open mitral valve repair or mitral valve replacement over 18 years old at Scientific Institute San Raffaele will be asked for their informed consent and enrolled in the present study.

Description

Inclusion Criteria:

  • All patients undergoing elective or urgent open mitral valve repair or mitral valve replacement over 18 years
  • Ability to sign informed consent
  • Availability of pre-CBP and after-CPB intraoperative transesophageal echocardiography which include a 4-chambers, 2-chambers and a long axis view at a minimum frame rate of 50 Hz
  • Good quality echocardiographic images with a optimal endocardial definition
  • Good quality ECG tracing

Exclusion Criteria:

  • All patients undergoing emergent open mitral valve repair or mitral valve replacement
  • Unavailability of pre-CBP and after-CPB intraoperative transesophageal echocardiography which include a 4-chambers, 2-chambers and a long axis view at a minimum frame rate of 50 Hz
  • Poor quality echocardiographic images
  • ECG artefacts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global longitudinal strain of myocardium in mitral valve surgery
Time Frame: Intraoperative 6 hours
Offline processing of GLS, GLS Rate
Intraoperative 6 hours
Number of patients with low cardiac output syndrome after mitral valve surgery
Time Frame: 30 days
30 days
Global longitudinal strain threshold associated with LCOS after mitral valve surgery
Time Frame: Intraoperative 6 hours
Intraoperative 6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: 30 days
30 days
Effect of general anesthesia on systole and diastole
Time Frame: Intraoperative 6 hours
Intraoperative 6 hours
All-cause mortality during the follow-up
Time Frame: 30 days and 1years
30 days and 1years
Length of intensive care unit stay
Time Frame: 30 days
30 days
30-day or in hospital mortality
Time Frame: 30 days
30 days
Duration of post-operative mechanical ventilation
Time Frame: 30 days
30 days
Post-operative rate of acute kidney injury
Time Frame: 30 days
30 days
Post-operative rate of hepatic dysfunction
Time Frame: 30 days
30 days
Readmission rate in intensive care
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2019

Primary Completion (Actual)

April 28, 2021

Study Completion (Actual)

November 26, 2021

Study Registration Dates

First Submitted

July 26, 2019

First Submitted That Met QC Criteria

August 2, 2019

First Posted (Actual)

August 5, 2019

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 3, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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