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Clinical Trials/NCT07101393
NCT07101393CompletedNot Applicable

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

Ataturk University1 site in 1 country150 target enrollmentStarted: December 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
150
Locations
1
Primary Endpoint
Incidence of Postoperative Stroke

Study Overview

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.

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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Postoperative Neurocognitive Impairment (PNCI)(Up to 7 days postoperatively or at hospital discharge)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ebubekir

PhD

Ataturk University

Study Sites (1)

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