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

NCT04045340 | Completed

• 1 other identifier: MIT-GO-2019
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mitral Valve Disease; Low Cardiac Output Syndrome

Outcome Measures

Primary Outcomes (3)

• Global longitudinal strain of myocardium in mitral valve surgery

  Offline processing of GLS, GLS Rate

  Intraoperative 6 hours

• Number of patients with low cardiac output syndrome after mitral valve surgery

  30 days

• Global longitudinal strain threshold associated with LCOS after mitral valve surgery

  Intraoperative 6 hours

Secondary Outcomes (9)

• Effect of general anesthesia on systole and diastole

  Intraoperative 6 hours

• All-cause mortality during the follow-up

  30 days and 1years

• Length of intensive care unit stay

  30 days

• Length of hospital stay

  30 days

• 30-day or in hospital mortality

  30 days

Interventions

Philips QLAB Ultrasound Quantification Software DEVICE

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

Also known as: Echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scientific Institute San Raffaele: lead

Study Sites (1)

Scientific Institute San Raffaele

Milan, 20132, Italy

Location

Related Publications (3)

• 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.

  PMID: 29200066 RESULT

• 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.

  PMID: 29116972 RESULT

• 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.

  PMID: 41126360 DERIVED

MeSH Terms

Conditions

Cardiac Output, Low

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiac and Vascular Anestesia

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 5, 2019
• Study Start: October 28, 2019
• Primary Completion: April 28, 2021
• Study Completion: November 26, 2021
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

IT (1)