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NCT07770269 · ClinicalTrials.gov record · last posted 2026-08-19

Assessment of Cardiac Function and Anesthesia Depth in Patients Undergoing Cardiac Surgery

Study acronym: SHAPE
StatusRecruiting
PhaseNot applicable
Started2026-01-19
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from the ClinicalTrials.gov record
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.
Trial Details
NCT Number NCT07770269
Lead Sponsor AHEPA University Hospital
Conditions Heart Disease
Enrollment 70 participants
Start Date 2026-01-19
Primary Completion 2026-11 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-19