Mitral Valve DiseaseMit-GONCT04045340
Intraoperative Global Longitudinal Strain and Global Longitudinal Strain Rate as Predictors of Unfavorable Outcome in On-Pump Mitral Surgery
An observational study of Mitral Valve Disease and Low Cardiac Output Syndrome, run by Scientific Institute San Raffaele at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Disease, Low Cardiac Output Syndrome
- What is being tested?
- Philips QLAB Ultrasound Quantification Software
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- 28 Oct 2019to 26 Nov 2021
- 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: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mitral Valve Disease, Low Cardiac Output Syndrome
- Being tested
- Philips QLAB Ultrasound Quantification Software
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips QLAB Ultrasound Quantification SoftwareDevice
Also called Echocardiography
Offline processing of intraoperative transesophageal echocardiography would be performed with Global Longitudinal Strain on apical 4 chamber, apical 2 chamber and long axis views in order to analyze left ventricle and left atrium contractility and right ventricle free wall motion
What is being measured
The primary outcome is the main question the study is designed to answer.
Global longitudinal strain of myocardium in mitral valve surgery
Offline processing of GLS, GLS Rate
Measured: Intraoperative 6 hours
Number of patients with low cardiac output syndrome after mitral valve surgery
Measured: 30 days
Global longitudinal strain threshold associated with LCOS after mitral valve surgery
Measured: Intraoperative 6 hours
Secondary outcomes (9)
Effect of general anesthesia on systole and diastole
Measured: Intraoperative 6 hours
All-cause mortality during the follow-up
Measured: 30 days and 1years
Length of intensive care unit stay
Measured: 30 days
Length of hospital stay
Measured: 30 days
30-day or in hospital mortality
Measured: 30 days
Duration of post-operative mechanical ventilation
Measured: 30 days
Post-operative rate of acute kidney injury
Measured: 30 days
Post-operative rate of hepatic dysfunction
Measured: 30 days
Readmission rate in intensive care
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start28 Oct 2019
- Primary completion28 Apr 2021
- Study completion26 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scientific Institute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio Monaco, Scientific Institute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045340
- Sponsor's protocol ID
- MIT-GO-2019
- Acronym
- Mit-GO
- Status last verified
- May 2026
- First submitted
- 26 Jul 2019
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 29200066Amabili 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.
PubMed 29116972Monaco 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.
PubMed 41126360
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04045340
- Acronym / sponsor ID
- Mit-GO / MIT-GO-2019
- Conditions
- Mitral Valve Disease, Low Cardiac Output Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Scientific Institute San RaffaeleUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 26 Nov 2021 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Philips QLAB Ultrasound Quantification SoftwareAlso: EchocardiographyOffline processing of intraoperative transesophageal echocardiography would be performed with Global Longitudinal Strain on apical 4 chamber, apical 2 chamber and long axis views in order to analyze left ventricle and left atrium contractility and right ventricle free wall motion | Device | – |
Primary outcome
Global longitudinal strain of myocardium in mitral valve surgery
Time frame: Intraoperative 6 hours
Offline processing of GLS, GLS Rate
Number of patients with low cardiac output syndrome after mitral valve surgery
Time frame: 30 days
Global longitudinal strain threshold associated with LCOS after mitral valve surgery
Time frame: Intraoperative 6 hours
9 secondary outcomes
Effect of general anesthesia on systole and diastole
Time frame: Intraoperative 6 hours
All-cause mortality during the follow-up
Time frame: 30 days and 1years
Length of intensive care unit stay
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
30-day or in hospital mortality
Time frame: 30 days
Duration of post-operative mechanical ventilation
Time frame: 30 days
Post-operative rate of acute kidney injury
Time frame: 30 days
Post-operative rate of hepatic dysfunction
Time frame: 30 days
Readmission rate in intensive care
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Results publication: PubMed 29200066Sonny 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.
- Results publication: PubMed 29116972Amabili 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.
- Derived from this study: PubMed 41126360Monaco 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Disease and Low Cardiac Output Syndrome, run by Scientific Institute San Raffaele at 1 site in Italy.
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 5 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 5 May 2026. 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 Italy. 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?
Global longitudinal strain of myocardium in mitral valve surgery (time frame: Intraoperative 6 hours). The study lists 3 primary outcomes in all. 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 NCT04045340, which also lists 3 linked publications.
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 5 May 2026.