NCT07770269 Assessment of Cardiac Function and Anesthesia Depth in Patients Undergoing Cardiac Surgery
| NCT ID | NCT07770269 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AHEPA University Hospital |
| Condition | Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-01-19 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2026-01-19 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Vasileios Kamperidis, Assistant Professor
STUDY CHAIR
1st Department of Cardiology, School of Medicine, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece
Frequently Asked Questions
Who can join the NCT07770269 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07770269 currently recruiting?
Yes, NCT07770269 is actively recruiting participants. Contact the research team at chrismantzios1994@gmail.com for enrollment information.
Where is the NCT07770269 trial being conducted?
This trial is being conducted at Thessaloniki, Greece.
Who is sponsoring the NCT07770269 clinical trial?
NCT07770269 is sponsored by AHEPA University Hospital. The principal investigator is Vasileios Kamperidis, Assistant Professor at 1st Department of Cardiology, School of Medicine, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece. The trial plans to enroll 70 participants.