NCT Number: NCT07770269
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Thessaloniki, 54636, Greece
Location status: Recruiting
Christos Mantzios, Cardiology Resident, MD, MSc
CONTACT
Christos Mantzios, Cardiology Resident, MD, MSc
PRINCIPAL_INVESTIGATOR
Despoina Sarridou, Associate Professor
SUB_INVESTIGATOR
Vasileos Kamperidis, Assistant Professor
SUB_INVESTIGATOR
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
AHEPA University Hospital
Other
Multifactorial Assessment of Cardiac Function Through Deformation Imaging, Hemodynamic Parameters, and Anesthesia-related Variables in Patients Undergoing Cardiac Surgery: The SHAPE Study
Acronym: SHAPE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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