CompletedNot Applicable

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

Italy140 participantsStarted 2019-10-28

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Global longitudinal strain of myocardium in mitral valve surgery

Timeframe: Intraoperative 6 hours

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

Timeframe: 30 days

Global longitudinal strain threshold associated with LCOS after mitral valve surgery

Timeframe: Intraoperative 6 hours

Trial details

NCT IDNCT04045340

SponsorScientific Institute San Raffaele

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-04-28

View on ClinicalTrials.gov More Mitral Valve Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Global longitudinal strain of myocardium in mitral valve surgery

Timeframe: Intraoperative 6 hours

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

Timeframe: 30 days

Global longitudinal strain threshold associated with LCOS after mitral valve surgery

Timeframe: Intraoperative 6 hours