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NCT Number: NCT07101393

Postoperative Stroke and Epiaortic Ultrasound in CABG

This study aims to investigate the incidence of postoperative stroke and neurocognitive impairment in patients undergoing coronary artery bypass grafting (CABG), with or without the use of epi-aortic ultrasound (EAU). Atherosclerosis in the ascending aorta is a known risk factor for perioperative stroke and systemic embolization. The identification of atherosclerotic plaques before manipulation of the ascending aorta is important in minimizing embolic complications. Neurocognitive function will be assessed using the standardized Mini-Mental State Examination (SMMSE) before surgery and within 7 days postoperatively or at discharge. This prospective, observational, case-control study will evaluate the relationship between the presence of atherosclerotic plaques detected by EAU and neurocognitive and neurologic outcomes following CABG surgery.

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Key information

Conditions

Postoperative Delirium Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Stroke Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

About this study

This is a prospective, observational case-control study designed to evaluate the association between the use of epi-aortic ultrasound (EAU) and the incidence of postoperative stroke and neurocognitive impairment following coronary artery bypass grafting (CABG) surgery. Patients undergoing elective CABG between December 2023 and December 2024 will be enrolled. Patients will be assigned to one of two groups based on the intraoperative use of EAU: the EAU group and the non-EAU group. EAU will be used to detect the presence, location, and characteristics of atherosclerotic plaques in the ascending aorta. Plaques will be categorized according to location and thickness (Stage 1-2: <3 mm, Stage 3-4-5: ≥3 mm). Neurocognitive function will be assessed preoperatively and postoperatively using the standardized Mini-Mental State Examination (SMMSE). Demographic variables and perioperative factors such as aortic cross-clamp time, cardiopulmonary bypass duration, and length of ICU stay will also be collected for analysis. The study aims to clarify the relationship between ascending aortic atherosclerosis detected by EAU and adverse neurological and cognitive outcomes, and to determine whether intraoperative EAU alters surgical decision-making.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for isolated, elective coronary artery bypass grafting (CABG)
  • Age 18 years or older

Exclusion criteria

  • Illiteracy (inability to read or write)
  • Visual and/or hearing impairment
  • Non-citizens/foreign nationals
  • Refusal to participate in the study
  • Presence of neuropsychiatric disorders that may affect postoperative cognitive evaluation (e.g., psychosis, dementia, mental retardation)
  • History of cerebrovascular accident (CVA/stroke)
  • Preoperative rhythm disturbances associated with stroke risk (e.g., atrial fibrillation, atrial flutter)
  • Presence of intracardiac thrombus (ventricular or atrial) on preoperative echocardiography
  • Patients undergoing concomitant cardiac procedures (e.g., valve or aortic surgery)
  • Emergency CABG surgery
  • Recent myocardial infarction
  • Use of intra-aortic balloon pump (IABP)
  • Redo CABG surgery
  • Significant carotid stenosis or plaque detected on preoperative carotid Doppler ultrasonography
  • Chronic renal failure and/or liver failure

Treatment and study plan

Intraoperative Epiaortic Ultrasound (EAU)

Procedure

Intraoperative epiaortic ultrasound (EAU) is a real-time imaging technique used during coronary artery bypass grafting (CABG) to evaluate the presence, location, and severity of atherosclerotic plaques in the ascending and arch aorta. In this study, EAU was performed after median sternotomy but prior to aortic manipulation, using a high-frequency linear transducer directly applied to the exposed aorta. Plaques were classified by thickness, and findings were used to guide surgical strategy, including modification of cannulation site, avoidance of cross-clamping, or alteration of grafting technique. This intervention differs from conventional CABG, in which such imaging is not routinely employed.

Other names: Epiaortic Scanning

Primary outcomes

  1. Incidence of Postoperative Stroke

    Time frame: Within 10 days postoperatively

    Occurrence of new-onset ischemic stroke confirmed by clinical neurological evaluation and neuroimaging (CT or MRI) within 10 days following coronary artery bypass grafting (CABG) surgery.

Secondary outcomes

  1. Postoperative Neurocognitive Impairment (PNCI)

    Time frame: Up to 7 days postoperatively or at hospital discharge

    Neurocognitive status was assessed using the Standardized Mini-Mental State Examination (SMMSE), which ranges from 0 to 30, with higher scores indicating better cognitive function. A score of <20 was defined as clinically significant neurocognitive impairment. Evaluations were performed preoperatively and repeated at discharge or within 7 days after surgery.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

Determination of Postoperative Stroke Incidence in Patients With and Without the Use of Epiaortic Ultrasound in Coronary Artery Bypass Grafting Surgery

Acronym: EAU and POCD

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

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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