Heart ultrasound during surgery may predict dangerous complication
NCT ID NCT04045340
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at 140 adults having mitral valve surgery to see if a special heart ultrasound measure (called global longitudinal strain) could predict a serious complication called low cardiac output syndrome. Researchers checked ultrasound images taken during surgery and tracked patient outcomes afterward. The goal was to find a better way to identify patients at risk, so doctors can intervene early.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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140 people
The number who actually took part.
- Started
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Oct 2019
- Finished
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Nov 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Scientific Institute San Raffaele
Milan, 20132, Italy
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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