Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-31 @ 7:32 PM
Study NCT ID:
NCT07101393
Status:
COMPLETED
Last Update Posted:
2025-08-03
First Post:
2025-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Stroke and Epiaortic Ultrasound in CABG
Sponsor:
Ataturk University
Organization:
Study Overview
Official Title:
Determination of Postoperative Stroke Incidence in Patients With and Without the Use of Epiaortic Ultrasound in Coronary Artery Bypass Grafting Surgery
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EAU and POCD
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: