Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Cardiac Function and Anesthesia Depth During Heart Surgery

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

Run by AHEPA University Hospital · NCT07770269 · Data updated 2026-11-12

This study tests whether deeper or lighter anesthesia affects heart function during elective heart surgery with bypass in adults.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment70 (estimated)
SponsorAHEPA University Hospital
Academic / other
Locations1 site (Thessaloniki)
StatusRecruiting
StartedJanuary 19, 2026
Main results expectedNovember 2026
Study endsNovember 2027
Registry record updatedAugust 19, 2026
Trial IDNCT07770269 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 years or older scheduled for elective on-pump cardiac surgery with a suitable acoustic window.

Probably not a fit

Patients with off-pump surgery or those not meeting echocardiography or consent criteria may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, parallel-group study, adults undergoing on-pump cardiac surgery are assigned to either a BIS-guided anesthesia depth of 45-55 or 30-35. Cardiac function is measured with transthoracic echocardiography including strain imaging and myocardial work, while invasive monitoring collects hemodynamic data. The primary goal is to compare changes in left ventricular global longitudinal strain between two intraoperative time points after induction and after separation from bypass. Outcome assessors are blinded to treatment allocation.

Why it matters

Potential benefit: If successful, the approach could help optimize anesthesia depth to preserve cardiac function during surgery.

How similar studies have gone: Previous work in related areas suggests that anesthesia depth can influence perioperative cardiac function, but this specific BIS-guided approach in on-pump surgery is novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • AHEPA University General Hospital of Thessaloniki
    Thessaloniki, Greece
    Recruiting

Study contacts

  • 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 coordinator: Christos Mantzios, Cardiology Resident, MD, MSc
  • Email: chrismantzios1994@gmail.com
  • Phone: +306983282188

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.