Assessment of Cardiac Function and Anesthesia Depth in Patients Undergoing Cardiac Surgery (SHAPE)

August 18, 2026 updated by: Christos Mantzios, AHEPA University Hospital

Multifactorial Assessment of Cardiac Function Through Deformation Imaging, Hemodynamic Parameters, and Anesthesia-related Variables in Patients Undergoing Cardiac Surgery: The SHAPE Study

The SHAPE study is a prospective, randomized study evaluating changes in cardiac function in adult patients undergoing cardiac surgery with cardiopulmonary bypass. The study focuses on how cardiac function changes during surgery and whether the depth of anesthesia may influence these changes.

Participants are randomly assigned to one of two levels of anesthesia depth, guided by the Bispectral Index (BIS). Cardiac function is assessed using transthoracic echocardiography, including myocardial deformation (strain) imaging and myocardial work measurements. Invasive hemodynamic measurements obtained during surgery are also recorded.

The primary objective is to assess the change in left ventricular global longitudinal strain (LV GLS) between two intraoperative time points: after induction of anesthesia and before cardiopulmonary bypass, and after separation from cardiopulmonary bypass. The study will also examine whether these changes differ according to the assigned depth of anesthesia and whether echocardiographic and hemodynamic measurements are associated with postoperative outcomes.

Participants will also undergo follow-up echocardiographic assessment at 3, 6, and 12 months after surgery to evaluate longer-term changes in cardiac function.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The SHAPE study is a prospective, randomized, parallel-group, single-masked interventional study conducted in adult patients undergoing elective cardiac surgery with cardiopulmonary bypass. The study is designed to investigate perioperative changes in myocardial function and to assess the potential influence of anesthesia depth on these changes.

Participants are randomized in a 1:1 ratio to two Bispectral Index (BIS)-guided anesthesia strategies: a BIS target of 45-55, representing standard anesthesia depth, or a BIS target of 30-35, representing deeper anesthesia. Total intravenous anesthesia with propofol and remifentanil is adjusted by the treating anesthesiologist to maintain the assigned BIS range. The echocardiographic outcome assessor remains blinded to treatment allocation during image acquisition, offline echocardiographic analysis, and primary outcome assessment.

Cardiac function is evaluated using transthoracic echocardiography and speckle-tracking analysis. Measurements include left ventricular global longitudinal strain (LV GLS), myocardial work indices, and additional indices of left- and right-sided cardiac function. Invasive hemodynamic monitoring using a Swan-Ganz catheter provides measurements including pulmonary capillary wedge pressure, cardiac output, cardiac index, pulmonary artery pressure, and right atrial pressure.

The primary analysis evaluates the within-participant change in LV GLS between two predefined intraoperative time points: after induction of anesthesia and before initiation of cardiopulmonary bypass (T1), and after separation from cardiopulmonary bypass (T2). Secondary analyses will assess whether the magnitude of perioperative changes in LV GLS and myocardial work differs between the two randomized BIS groups and will explore associations between echocardiographic measurements, invasive hemodynamic parameters, and postoperative clinical outcomes.

Postoperative outcomes include low cardiac output syndrome, requirement for inotropic or vasopressor support, postoperative atrial fibrillation, duration of mechanical ventilation, and length of intensive care unit stay. Echocardiographic follow-up is performed at 3, 6, and 12 months after surgery to assess longer-term changes in cardiac function.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54636
        • Recruiting
        • AHEPA University General Hospital of Thessaloniki
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christos Mantzios, Cardiology Resident, MD, MSc
        • Sub-Investigator:
          • Vasileos Kamperidis, Assistant Professor
        • Sub-Investigator:
          • Despoina Sarridou, Associate Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 years or older, irrespective of sex.
  • Scheduled to undergo elective cardiac surgery involving cardiopulmonary bypass (on-pump surgery).
  • Anticipated adequate acoustic window for transthoracic echocardiography.
  • Provision of written informed consent.

Exclusion Criteria:

  • - Emergency or unscheduled cardiac surgery.
  • Cardiac surgery without cardiopulmonary bypass (off-pump surgery).
  • Refusal or inability to provide written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: BIS 45-55
Participants assigned to this arm will receive total intravenous anesthesia with propofol and remifentanil, adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 45-55, representing standard anesthesia depth.
Other: BIS-guided anesthesia: BIS 45-55
Total intravenous anesthesia with propofol and remifentanil will be adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 45-55, representing standard anesthesia depth.
Experimental: BIS 30-35
Participants assigned to this arm will receive total intravenous anesthesia with propofol and remifentanil, adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 30-35, representing deeper anesthesia.
Other: BIS-guided anesthesia: BIS 30-35
Total intravenous anesthesia with propofol and remifentanil will be adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 30-35, representing deeper anesthesia.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Within-Participant Change in Left Ventricular Global Longitudinal Strain (LV GLS) From T1 to T2
Time Frame: During index cardiac surgery: T1 after induction of anesthesia and before cardiopulmonary bypass; T2 after separation from cardiopulmonary bypass.
Left ventricular global longitudinal strain (LV GLS) will be assessed by speckle-tracking echocardiography at two predefined intraoperative time points: T1, after induction of anesthesia and before initiation of cardiopulmonary bypass, and T2, after separation from cardiopulmonary bypass. The primary outcome will be the within-participant change in LV GLS, calculated as T2 minus T1 and expressed in percentage points. Because LV GLS is expressed as a negative value, a positive T2-minus-T1 difference indicates a reduction in the absolute magnitude of LV GLS and therefore deterioration in longitudinal systolic function.
During index cardiac surgery: T1 after induction of anesthesia and before cardiopulmonary bypass; T2 after separation from cardiopulmonary bypass.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Left Ventricular Global Longitudinal Strain (LV GLS) From T1 to T2 by Randomized BIS Group
Time Frame: During index cardiac surgery: from T1 before cardiopulmonary bypass to T2 after separation from cardiopulmonary bypass.
Left ventricular global longitudinal strain (LV GLS) will be assessed by speckle-tracking echocardiography at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass. The within-participant change in LV GLS (T2 minus T1), expressed in percentage points, will be compared between participants randomized to the BIS 45-55 and BIS 30-35 groups.
During index cardiac surgery: from T1 before cardiopulmonary bypass to T2 after separation from cardiopulmonary bypass.
Change in Left Ventricular Myocardial Work Indices From T1 to T2 by Randomized BIS Group
Time Frame: During index cardiac surgery: from T1, before cardiopulmonary bypass, to T2, after separation from cardiopulmonary bypass.
Left ventricular myocardial work will be assessed using non-invasive pressure-strain loops at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass. Myocardial work indices will include Global Work Index (GWI), Global Constructive Work (GCW), Global Wasted Work (GWW), and Global Work Efficiency (GWE). Changes from T1 to T2 will be assessed within participants and compared between the BIS 45-55 and BIS 30-35 groups.
During index cardiac surgery: from T1, before cardiopulmonary bypass, to T2, after separation from cardiopulmonary bypass.
Postoperative Adverse Clinical Events
Time Frame: From completion of index cardiac surgery through discharge during the index hospitalization, assessed up to 60 days after surgery.
Postoperative adverse clinical events will include the occurrence of low cardiac output syndrome (LCOS), requirement for inotropic or vasopressor support, and postoperative atrial fibrillation (POAF). Each event will be recorded during the postoperative hospitalization and evaluated in relation to perioperative echocardiographic, hemodynamic, and anesthesia-related parameters.
From completion of index cardiac surgery through discharge during the index hospitalization, assessed up to 60 days after surgery.
Duration of Mechanical Ventilation
Time Frame: From completion of index cardiac surgery until successful extubation during the index hospitalization, assessed up to 60 days after surgery.
The duration of postoperative mechanical ventilation will be recorded as the time from completion of index cardiac surgery until successful extubation. Duration will be expressed in minutes and analyzed in relation to perioperative echocardiographic, hemodynamic, and anesthesia-related parameters.
From completion of index cardiac surgery until successful extubation during the index hospitalization, assessed up to 60 days after surgery.
Length of Intensive Care Unit Stay
Time Frame: From postoperative ICU admission until ICU discharge during the index hospitalization, assessed up to 60 days after surgery.
The length of stay in the intensive care unit (ICU) will be recorded as the duration from postoperative admission to the ICU until discharge from the ICU. Duration will be expressed in days and analyzed in relation to perioperative echocardiographic, hemodynamic, and anesthesia-related parameters.
From postoperative ICU admission until ICU discharge during the index hospitalization, assessed up to 60 days after surgery.
Change in Left Ventricular Global Longitudinal Strain During Follow-up
Time Frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Left ventricular global longitudinal strain (LV GLS) will be assessed by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). LV GLS will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Left Ventricular Global Work Index During Follow-up
Time Frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Left ventricular Global Work Index (GWI) will be assessed using non-invasive pressure-strain loop analysis and expressed in mmHg%. GWI will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Left Ventricular Global Constructive Work During Follow-up
Time Frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Left ventricular Global Constructive Work (GCW) will be assessed using non-invasive pressure-strain loop analysis and expressed in mmHg%. GCW will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Left Ventricular Global Wasted Work During Follow-up
Time Frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Left ventricular Global Wasted Work (GWW) will be assessed using non-invasive pressure-strain loop analysis and expressed in mmHg%. GWW will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Left Ventricular Global Work Efficiency During Follow-up
Time Frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Left ventricular Global Work Efficiency (GWE) will be assessed using non-invasive pressure-strain loop analysis and expressed as a percentage (%). GWE will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Right Ventricular Free-Wall Strain During Follow-up
Time Frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Right ventricular free-wall strain (RV FWS) will be assessed by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). RV FWS will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Right Atrial Strain During Follow-up
Time Frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Right atrial strain (RA strain) will be assessed by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). RA strain will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in Tricuspid Annular Plane Systolic Excursion During Follow-up
Time Frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Tricuspid annular plane systolic excursion (TAPSE) will be assessed by transthoracic echocardiography and expressed in millimeters (mm). TAPSE will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Presence of Paradoxical Septal Motion During Follow-up
Time Frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Interventricular septal motion will be assessed by transthoracic echocardiography and classified according to the presence or absence of paradoxical septal motion (PSM). PSM status will be recorded preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery to evaluate its postoperative evolution.
Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Change in TAPSE/sPAP Ratio During Follow-up
Time Frame: Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
The ratio of tricuspid annular plane systolic excursion to systolic pulmonary artery pressure (TAPSE/sPAP), an echocardiographic index of right ventricular-pulmonary arterial coupling, will be assessed by transthoracic echocardiography and expressed in mm/mmHg. The TAPSE/sPAP ratio will be measured preoperatively and reassessed at 3, 6, and 12 months after cardiac surgery. Changes at each follow-up time point will be evaluated relative to the preoperative baseline value.
Preoperative baseline and 3, 6, and 12 months after index cardiac surgery.
Correlation Between Left Ventricular Global Longitudinal Strain and Pulmonary Capillary Wedge Pressure
Time Frame: During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Left ventricular global longitudinal strain (LV GLS) will be assessed by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter and expressed in mmHg. Both measurements will be obtained at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass. The correlation between LV GLS and PCWP will be assessed at each time point using Pearson's or Spearman's correlation coefficient, as appropriate.
During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Correlation Between Left Ventricular Global Work Index and Pulmonary Capillary Wedge Pressure
Time Frame: During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Left ventricular Global Work Index (GWI) will be assessed using non-invasive pressure-strain loop analysis and expressed in mmHg%. Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter and expressed in mmHg. Both measurements will be obtained at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass. The correlation between GWI and PCWP will be assessed at each time point using Pearson's or Spearman's correlation coefficient, as appropriate.
During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Correlation Between Left Ventricular Global Constructive Work and Pulmonary Capillary Wedge Pressure
Time Frame: During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Left ventricular Global Constructive Work (GCW) will be assessed using non-invasive pressure-strain loop analysis and expressed in mmHg%. Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter and expressed in mmHg. Both measurements will be obtained at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass. The correlation between GCW and PCWP will be assessed at each time point using Pearson's or Spearman's correlation coefficient, as appropriate.
During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Correlation Between Left Ventricular Global Wasted Work and Pulmonary Capillary Wedge Pressure
Time Frame: During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Left ventricular Global Wasted Work (GWW) will be assessed using non-invasive pressure-strain loop analysis and expressed in mmHg%. Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter and expressed in mmHg. Both measurements will be obtained at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass. The correlation between GWW and PCWP will be assessed at each time point using Pearson's or Spearman's correlation coefficient, as appropriate.
During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Correlation Between Left Ventricular Global Work Efficiency and Pulmonary Capillary Wedge Pressure
Time Frame: During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Left ventricular Global Work Efficiency (GWE) will be assessed using non-invasive pressure-strain loop analysis and expressed as a percentage (%). Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter and expressed in mmHg. Both measurements will be obtained at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass. The correlation between GWE and PCWP will be assessed at each time point using Pearson's or Spearman's correlation coefficient, as appropriate.
During index cardiac surgery at T1, after induction of anesthesia and before cardiopulmonary bypass, and at T2, after separation from cardiopulmonary bypass.
Correlation Between Preoperative Right Atrial Strain and Intraoperative Pulmonary Capillary Wedge Pressure
Time Frame: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative PCWP assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Preoperative right atrial strain (RA strain) will be assessed by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter at T1 and expressed in mmHg. The correlation between preoperative RA strain and PCWP will be assessed using Pearson's or Spearman's correlation coefficient, as appropriate.
Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative PCWP assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative Right Atrial Strain and Intraoperative Cardiac Index
Time Frame: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative cardiac index assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Preoperative right atrial strain (RA strain) will be assessed by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). Cardiac index (CI) will be measured invasively using a Swan-Ganz catheter at T1 and expressed in L/min/m². The correlation between preoperative RA strain and CI will be assessed using Pearson's or Spearman's correlation coefficient, as appropriate.
Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative cardiac index assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative Right Ventricular Free-Wall Strain and Intraoperative Pulmonary Capillary Wedge Pressure
Time Frame: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative PCWP assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Preoperative right ventricular free-wall strain (RV FWS) will be assessed by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter at T1 and expressed in mmHg. The correlation between preoperative RV FWS and PCWP will be assessed using Pearson's or Spearman's correlation coefficient, as appropriate.
Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative PCWP assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative Right Ventricular Free-Wall Strain and Intraoperative Cardiac Index
Time Frame: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative cardiac index assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Preoperative right ventricular free-wall strain (RV FWS) will be assessed by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). Cardiac index (CI) will be measured invasively using a Swan-Ganz catheter at T1 and expressed in L/min/m². The correlation between preoperative RV FWS and CI will be assessed using Pearson's or Spearman's correlation coefficient, as appropriate.
Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative cardiac index assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative TAPSE/sPAP Ratio and Intraoperative Pulmonary Capillary Wedge Pressure
Time Frame: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative PCWP assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
The preoperative TAPSE/sPAP ratio will be assessed by transthoracic echocardiography and expressed in mm/mmHg. Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter at T1 and expressed in mmHg. The correlation between the preoperative TAPSE/sPAP ratio and PCWP will be assessed using Pearson's or Spearman's correlation coefficient, as appropriate.
Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative PCWP assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative TAPSE/sPAP Ratio and Intraoperative Cardiac Index
Time Frame: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative cardiac index assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
The preoperative TAPSE/sPAP ratio will be assessed by transthoracic echocardiography and expressed in mm/mmHg. Cardiac index (CI) will be measured invasively using a Swan-Ganz catheter at T1 and expressed in L/min/m². The correlation between the preoperative TAPSE/sPAP ratio and CI will be assessed using Pearson's or Spearman's correlation coefficient, as appropriate.
Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative cardiac index assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
Correlation Between Preoperative E/LA Strain Ratio and Intraoperative Pulmonary Capillary Wedge Pressure
Time Frame: Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative PCWP assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.
The preoperative E/LA strain ratio will be calculated as the ratio of early diastolic transmitral flow velocity (E), measured by pulsed-wave Doppler echocardiography and expressed in cm/s, to left atrial strain, measured by speckle-tracking transthoracic echocardiography and expressed as a percentage (%). The E/LA strain ratio will be expressed in cm/s/%. Pulmonary capillary wedge pressure (PCWP) will be measured invasively using a Swan-Ganz catheter at T1 and expressed in mmHg. The correlation between the preoperative E/LA strain ratio and intraoperative PCWP will be assessed using Pearson's or Spearman's correlation coefficient, as appropriate.
Preoperative transthoracic echocardiography within 24 hours before surgery and intraoperative PCWP assessment at T1, after induction of anesthesia and before cardiopulmonary bypass.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AHEPA University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Vasileios Kamperidis, Assistant Professor, 1st Department of Cardiology, School of Medicine, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece
  • Study Director: Despoina Sarridou, Associate Professor, Department of Anesthesiology, AHEPA University Hospital, Aristotle University of Thessaloniki
  • Study Director: Helena Argiriadou, Professor, Department of Anesthesiology and Intensive Care, AHEPA University Hospital, Aristotle University of Thessaloniki
  • Study Director: Antonios Ziakas, Professor, 1st Department of Cardiology, School of Medicine, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece
  • Principal Investigator: Christos Mantzios, Cardiology Resident, MD, MSc, 1st Department of Cardiology, School of Medicine, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHAPE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant-level data will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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