Postoperative Stroke and Epiaortic Ultrasound in CABG

NCT07101393 | Completed

• 1 other identifier: ES-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Delirium; Postoperative Stroke

Keywords

Epiaortic Ultrasound; Coronary Artery Bypass Grafting; Stroke; Postoperative Neurocognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Stroke

  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.

  Within 10 days postoperatively

Secondary Outcomes (1)

• Postoperative Neurocognitive Impairment (PNCI)

  Up to 7 days postoperatively or at hospital discharge

Study Arms (1)

EAU Use in CABG

This cohort includes patients who underwent isolated coronary artery bypass grafting (CABG) surgery between December 2023 and December 2024. The intervention group (EAU group) consisted of patients in whom epiaortic ultrasound (EAU) was used intraoperatively to assess atherosclerotic burden in the ascending and arch aorta. Findings from EAU guided intraoperative decision-making, including cannulation site and cross-clamp strategy. The control group comprised patients who underwent CABG without EAU. The primary outcomes evaluated were postoperative stroke incidence and neurocognitive impairment.

Procedure: Intraoperative Epiaortic Ultrasound (EAU)

Interventions

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.

Also known as: Epiaortic Scanning

EAU Use in CABG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of adult patients (aged ≥18 years) who underwent isolated, elective coronary artery bypass grafting (CABG) surgery at a single cardiovascular surgery center between December 2023 and December 2024. All participants were evaluated preoperatively for eligibility based on cognitive and clinical criteria. Patients were assigned to either the intervention group (with intraoperative epiaortic ultrasound use) or the control group (without EAU use). Individuals with neuropsychiatric disorders, prior stroke, rhythm disturbances, or other major comorbidities were excluded to ensure reliable neurocognitive assessment.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (1)

• Shapeton AD, Leissner KB, Zorca SM, Amirfarzan H, Stock EM, Biswas K, Haime M, Srinivasa V, Quin JA, Zenati MA. Epiaortic Ultrasound for Assessment of Intraluminal Atheroma; Insights from the REGROUP Trial. J Cardiothorac Vasc Anesth. 2020 Mar;34(3):726-732. doi: 10.1053/j.jvca.2019.10.053. Epub 2019 Nov 9.

  PMID: 31787434 RESULT

MeSH Terms

Conditions

Emergence Delirium; Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• ebubekir sonmez

  Ataturk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: August 3, 2025
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)