- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04045340
Intraoperative Global Longitudinal Strain and Global Longitudinal Strain Rate as Predictors of Unfavorable Outcome in On-Pump Mitral Surgery (Mit-GO)
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Milan, Italy, 20132
- Scientific Institute San Raffaele
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
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Offline processing of GLS, GLS Rate
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Intraoperative 6 hours
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Number of patients with low cardiac output syndrome after mitral valve surgery
Time Frame: 30 days
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30 days
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Global longitudinal strain threshold associated with LCOS after mitral valve surgery
Time Frame: Intraoperative 6 hours
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Intraoperative 6 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Length of hospital stay
Time Frame: 30 days
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30 days
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Effect of general anesthesia on systole and diastole
Time Frame: Intraoperative 6 hours
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Intraoperative 6 hours
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All-cause mortality during the follow-up
Time Frame: 30 days and 1years
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30 days and 1years
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Length of intensive care unit stay
Time Frame: 30 days
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30 days
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30-day or in hospital mortality
Time Frame: 30 days
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30 days
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Duration of post-operative mechanical ventilation
Time Frame: 30 days
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30 days
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Post-operative rate of acute kidney injury
Time Frame: 30 days
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30 days
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Post-operative rate of hepatic dysfunction
Time Frame: 30 days
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30 days
|
|
Readmission rate in intensive care
Time Frame: 30 days
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30 days
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Sonny A, Alfirevic A, Sale S, Zimmerman NM, You J, Gillinov AM, Sessler DI, Duncan AE. Reduced Left Ventricular Global Longitudinal Strain Predicts Prolonged Hospitalization: A Cohort Analysis of Patients Having Aortic Valve Replacement Surgery. Anesth Analg. 2018 May;126(5):1484-1493. doi: 10.1213/ANE.0000000000002684.
- Amabili P, Benbouchta S, Roediger L, Senard M, Hubert MB, Donneau AF, Brichant JF, Hans GA. Low Cardiac Output Syndrome After Adult Cardiac Surgery: Predictive Value of Peak Systolic Global Longitudinal Strain. Anesth Analg. 2018 May;126(5):1476-1483. doi: 10.1213/ANE.0000000000002605.
- Monaco F, Bonaccorso A, D'Andria Ursoleo J, Pruna A, Lerose CC, Di Prima AL, Barucco G, Landoni G, Licheri M; Mit-Go Study Group Collaborators. Intraoperative global longitudinal strain and strain rate as predictors of unfavorable outcome following on-pump mitral surgery: a prospective observational study. J Anesth Analg Crit Care. 2025 Oct 22;5(1):70. doi: 10.1186/s44158-025-00288-1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Heart Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Cardiac Output, Low
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Imaging
- Diagnostic Techniques, Cardiovascular
- Heart Function Tests
- Cardiac Imaging Techniques
- Ultrasonography
- Echocardiography
Other Study ID Numbers
- MIT-GO-2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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