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Cohort Study of Postoperative Cognitive Dysfunction After Off-Pump Coronary Artery Bypass Grafting (OPCAB-POCD)

9 juni 2026 uppdaterad av: Beijing Anzhen Hospital

Risk of Postoperative Cognitive Dysfunction After Off-Pump Coronary Artery Bypass Grafting: A Prospective Cohort Study

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This is a prospective observational cohort study of patients undergoing off-pump coronary artery bypass grafting. The study aims to investigate postoperative cognitive dysfunction and its association with perioperative clinical factors. Eligible patients will be enrolled before surgery and followed after surgery according to the study protocol.

Baseline information will be collected before surgery, including demographic characteristics, medical history, comorbidities, laboratory test results, and preoperative cognitive assessment. Intraoperative and postoperative data will also be collected, including anesthesia-related variables, surgical information, hemodynamic and monitoring parameters, postoperative clinical status, and relevant complications.

Cognitive function will be assessed before surgery and at predefined postoperative time points using standardized cognitive assessment tools, such as the Montreal Cognitive Assessment. Postoperative cognitive dysfunction will be determined according to the predefined criteria based on changes in cognitive assessment results from baseline to postoperative follow-up.

The study will describe the incidence of postoperative cognitive dysfunction after off-pump coronary artery bypass grafting and evaluate the association between perioperative factors and postoperative cognitive outcomes. The results may help improve understanding of postoperative cognitive dysfunction in this surgical population and provide evidence for perioperative risk assessment and clinical management.

Studietyp

Observationell

Inskrivning (Beräknad)

600

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100029
        • Beijing Anzhen Hospital, Capital Medical University
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

Inclusion Criteria:

  • 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
  • Written informed consent provided by the patient or family member

Exclusion Criteria:

  • 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
  • Severe visual or hearing impairment that prevents completion of cognitive assessment
  • Inability to understand Chinese or presence of language communication barriers

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Off-Pump Coronary Artery Bypass Grafting Cohort
Patients undergoing off-pump coronary artery bypass grafting who will receive preoperative cognitive assessment and postoperative follow-up for postoperative cognitive dysfunction. Perioperative clinical information, including preoperative assessment data, intraoperative monitoring parameters, and postoperative clinical data, will be collected.
Procedur: Off-Pump Coronary Artery Bypass Grafting
Off-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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of Postoperative Cognitive Dysfunction
Tidsram: Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7
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.
Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Montreal Cognitive Assessment Score
Tidsram: Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7
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.
Postoperative Day 7, or 1 Day Before Hospital Discharge if Discharged Before Postoperative Day 7
Length of Intensive Care Unit Stay
Tidsram: through ICU discharge, an average of 3 days
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.
through ICU discharge, an average of 3 days
Length of Postoperative Hospital Stay
Tidsram: through hospital discharge, an average of 7 days
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.
through hospital discharge, an average of 7 days
Incidence of Postoperative Complications
Tidsram: through hospital discharge, an average of 7 days
Postoperative complications during hospitalization will be recorded, including cardiovascular, respiratory, neurological, renal, infectious, thromboembolic, and wound-related complications.
through hospital discharge, an average of 7 days
Duration of Postoperative Mechanical Ventilation
Tidsram: through ICU stay, an average of 3 days
The duration of postoperative mechanical ventilation will be recorded as the time from postoperative intensive care unit admission to successful discontinuation of mechanical ventilation.
through ICU stay, an average of 3 days
Incidence of Postoperative Nausea and Vomiting
Tidsram: through hospital discharge, an average of 7 days
Postoperative nausea and vomiting during the postoperative hospitalization period will be recorded based on medical records.
through hospital discharge, an average of 7 days
Incidence of In-Hospital Mortality
Tidsram: through hospital discharge, an average of 7 days
In-hospital mortality will be recorded as death from any cause during the postoperative hospitalization period.
through hospital discharge, an average of 7 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Beijing Anzhen Hospital

Utredare

  • Huvudutredare: Wenjun Liu, PhD, Beijing Anzhen Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

24 maj 2026

Primärt slutförande (Beräknad)

24 november 2026

Avslutad studie (Beräknad)

15 december 2026

Studieregistreringsdatum

Först inskickad

24 maj 2026

Först inskickad som uppfyllde QC-kriterierna

9 juni 2026

Första postat (Faktisk)

11 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 juni 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • POCD-MOCA-2026-001
  • L252086 (Annat bidrag/finansieringsnummer: Beijing Natural Science Foundation)
  • KS2025225 (Annan identifierare: Ethics Committee of Beijing Anzhen Hospital, Capital Medical University)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Individual participant data will not be shared due to privacy, ethical, and institutional data protection considerations.

Läkemedels- och apparatinformation, studiedokument

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