Cohort Study of Postoperative Cognitive Dysfunction After Off-Pump Coronary Artery Bypass Grafting
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital
About this trial
This prospective cohort study aims to investigate postoperative cognitive dysfunction in patients undergoing off-pump coronary artery bypass grafting. Eligible patients will be enrolled before surgery and followed after surgery. Cognitive function will be assessed using the Montreal Cognitive Assessment before surgery and at predefined postoperative time points. Perioperative clinical information, including preoperative assessment data, intraoperative monitoring parameters, and postoperative clinical data, will be collected. The study will evaluate the occurrence of postoperative cognitive dysfunction and explore its association with perioperative factors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Scheduled to undergo elective off-pump coronary artery bypass grafting
American Society of Anesthesiologists physical status classification I to IV
Able to complete preoperative cognitive assessments, including the Mini-Mental State Examination and the Montreal Cognitive Assessment
Disqualifiers
Emergency surgery
Pre-existing diagnosed cognitive impairment or history of psychiatric disease
Preoperative cognitive impairment
Severe neurological disease, such as sequelae of stroke, that may interfere with cognitive assessment
Trial population
Adult patients scheduled to undergo elective off-pump coronary artery bypass grafting at Beijing Anzhen Hospital, Capital Medical University, will be prospectively enrolled. Eligible patients must be able to complete preoperative cognitive assessments and provide informed consent. Patients will be followed after surgery to evaluate postoperative cognitive dysfunction.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Off-Pump Coronary Artery Bypass Grafting
Procedure/SurgeryOff-pump coronary artery bypass grafting is performed as part of routine clinical care for patients with coronary artery disease. The study protocol does not assign participants to this procedure or to any additional intervention. This observational study will collect perioperative clinical data and follow patients after surgery to assess postoperative cognitive dysfunction.
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: Off-Pump Coronary Artery Bypass Grafting Cohort1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Postoperative Cognitive Dysfunction
Postoperative cognitive dysfunction will be evaluated by comparing postoperative Montreal Cognitive Assessment scores with preoperative baseline scores. Preoperative cognitive function will be assessed using the Montreal Cognitive Assessment 1 day after hospital admission. Postoperative cognitive function will be assessed using the Montreal Cognitive Assessment on postoperative day 7 or, if the patient is discharged before postoperative day 7, 1 day before hospital discharge. Postoperative cognitive dysfunction is defined as a decline in the postoperative Montreal Cognitive Assessment score of at least 1 standard deviation compared with the preoperative baseline score.
Time frame
Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7Secondary outcomes
1
Change in Montreal Cognitive Assessment Score
The change in Montreal Cognitive Assessment score will be calculated by comparing the postoperative score with the preoperative baseline score. Preoperative cognitive function will be assessed 1 day after hospital admission, and postoperative cognitive function will be assessed on postoperative day 7 or, if the patient is discharged before postoperative day 7, 1 day before hospital discharge.
Time frame
Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 72
Length of Intensive Care Unit Stay
The length of intensive care unit stay will be recorded as the number of days from admission to the intensive care unit after surgery to discharge from the intensive care unit.
Time frame
through ICU discharge, an average of 3 days3
Length of Postoperative Hospital Stay
The length of postoperative hospital stay will be recorded as the number of days from the date of surgery to the date of hospital discharge.
Time frame
through hospital discharge, an average of 7 days4
Incidence of Postoperative Complications
Postoperative complications during hospitalization will be recorded, including cardiovascular, respiratory, neurological, renal, infectious, thromboembolic, and wound-related complications.
Time frame
through hospital discharge, an average of 7 daysSponsors and contacts
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Source ClinicalTrials.gov
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