Postoperative DeliriumEAU and POCDNCT07101393
Postoperative Stroke and Epiaortic Ultrasound in CABG
An observational study of Postoperative Delirium and Postoperative Stroke, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium, Postoperative Stroke
- What is being tested?
- Intraoperative Epiaortic Ultrasound (EAU)
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients scheduled for isolated, elective coronary artery bypass grafting (CABG)
- Age 18 years or older
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Postoperative Stroke Incidence in Patients With and Without the Use of Epiaortic Ultrasound in Coronary Artery Bypass Grafting Surgery
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.
Read the detailed description
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.
- Conditions
- Postoperative Delirium, Postoperative Stroke
- Being tested
- Intraoperative Epiaortic Ultrasound (EAU)
- Keywords
- Epiaortic Ultrasound, Coronary Artery Bypass Grafting, Stroke, Postoperative Neurocognitive Impairment
- Medical subject headings
- Emergence Delirium, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Epiaortic Ultrasound (EAU)Procedure or surgery
Also called Epiaortic Scanning
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Intraoperative Epiaortic Ultrasound (EAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 10 days postoperatively
Secondary outcomes (1)
Postoperative Neurocognitive Impairment (PNCI)
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.
Measured: Up to 7 days postoperatively or at hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Dec 2023
- Primary completion1 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebubekir, Ataturk University
- Investigators
- ebubekir sonmez, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101393
- Sponsor's protocol ID
- ES-01
- Acronym
- EAU and POCD
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made publicly available due to institutional policies and the potential for overlapping use of the same dataset by other researchers within the institution. However, data may be shared upon reasonable request, provided that appropriate ethical approvals and data-sharing agreements are in place
Publications
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.
PubMed 31787434
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Postoperative Stroke Incidence in Patients With and Without the Use of Epiaortic Ultrasound in Coronary Artery Bypass Grafting Surgery
- ClinicalTrials.gov ID
- NCT07101393
- Acronym / sponsor ID
- EAU and POCD / ES-01
- Conditions
- Postoperative Delirium, Postoperative Stroke
- Keywords
- Epiaortic Ultrasound, Coronary Artery Bypass Grafting, Stroke, Postoperative Neurocognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EAU Use in CABG | – | Procedure: Intraoperative Epiaortic Ultrasound (EAU)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients scheduled for isolated, elective coronary artery bypass grafting (CABG)
- Age 18 years or older
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative Epiaortic Ultrasound (EAU)Also: Epiaortic ScanningIntraoperative 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. | Procedure or surgery | EAU Use in CABG |
Primary outcome
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.
1 secondary outcome
Postoperative Neurocognitive Impairment (PNCI)
Time frame: Up to 7 days postoperatively or at hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Results publication: PubMed 31787434Shapeton 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made publicly available due to institutional policies and the potential for overlapping use of the same dataset by other researchers within the institution. However, data may be shared upon reasonable request, provided that appropriate ethical approvals and data-sharing agreements are in place
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ebubekir sonmez principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium and Postoperative Stroke, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Stroke (time frame: Within 10 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07101393, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.