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PRECISION: A Prospective Cohort Study of Perioperative Covert Stroke and Postoperative Cognitive Dysfunction

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03081429
Collaborator
(none)
1,100
Enrollment
1
Location
52.3
Anticipated Duration (Months)
21
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

With the development of population aging, the incidence of covert stroke and cognitive dysfunction gradually increased. Currently, there is still lack of prospective cohort study with large sample size on the relationship between perioperative covert stroke and postoperative cognitive dysfunction. The investigators will perform a prospective cohort study. The aim of the study is to determine whether there is an association between perioperative covert stroke and postoperative cognitive dysfunction in elderly patients undergoing noncardiac surgery.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Cohort Study of Perioperative Covert Stroke and Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Noncardiac Surgery
    Actual Study Start Date :
    May 23, 2018
    Anticipated Primary Completion Date :
    Mar 31, 2022
    Anticipated Study Completion Date :
    Sep 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Perioperative covert stroke
    Postoperative cognitive dysfunction

    Outcome Measures

    Primary Outcome Measures

    1. The incidence of perioperative covert stroke [Postoperative 3-7 days]

      Stroke is diagnosed by MRI

    Secondary Outcome Measures

    1. Postoperative cognitive function [1 day before surgery; and 3 months, 1 year after surgery]

      Cognitive assessment will be conducted by trained research members who are blinded to the clinical diagnosis, treatment and MRI. The Mini-mental State Examination (MMSE) and Montreal cognitive assessment-basic (MoCA-B) will be used to assess the cognitive function. Postoperative cognitive dysfunction is defined as at least 2 standard deviation reduction in either assessment of MMSE or MoCA-B.

    2. Postoperative delirium [4 hours, 24 hours, and 7 days after surgery]

      The Confusion Assessment Method for the Intensive Care Unit scale (CAM-ICU) will be applied to assess delirium.

    3. Recovery quality [1 day before surgery; and 30 days, 3 months after surgery]

      The Modified Rankin Scale (mRS) and Lawton instrumental activities of daily living scale (IADL) will be applied to assess the recovery quality.

    4. Plasma hypersensitive C-reactive protein, neurofilament light chain, and β Amyloid level [At anesthesia induction and at the end of surgery]

      Peripheral artery blood samples (4 ml) will be taken at anesthesia induction and at the end of surgery respectively. The blood samples will be stored in vacutainer tubes containing the anticoagulant EDTA and centrifuged at 4°C. Then, the blood samples will be centrifugated for 8 minutes at 3000 revolutions per minute, and then plasma will be pipetted into Eppendorf tubes (Becton Dickinson). The plasma samples will be stored at -80°C. All plasma samples will be analyzed in a single run in the laboratory of Beijing Tiantan Hospital by board-certified laboratory technicians blind to clinical data using a single batch of reagents for each assay. A multiplex panel consisting of hs-CRP, NFL, and β Amyloid will be applied. The cytokines will be quantified using an in-house assay and a sensitive electrochemiluminescence-based platform (Quickplex, Meso-Scale Discovery®, MD).

    5. The quality of life [1 day before surgery; and 30 days, 3 months after surgery]

      The quality of life will be assessed with the EuroQol-5D (EQ-5D) scale.

    6. Depression state [1 day before surgery; and 30 days, 3 months after surgery]

      Depression state will be assessed with the Geriatric Depression Scale.

    7. The incidence of comorbidity. [30 days and 3 months after surgery]

      The incidence of myocardial infarction, cardiac arrest, pulmonary embolism, sepsis, surgical site infection and persistent postoperative pain.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients schedule to receive elective noncardiac surgery under general anesthesia from 2018 to 2021 will be included in the trial. Other criteria include age older than 60 years old.
    Exclusion Criteria:
    • Patients have MRI contraindications, and cannot complete the cognitive evaluation and refuse to sign informed consent will be excluded from the trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing TianTan Hospital Beijing China 100070

    Sponsors and Collaborators

    • Beijing Tiantan Hospital

    Investigators

    • Study Chair: Ruquan Han, M.D., Ph.D, Department of Anesthesiology, Beijing Tiantan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuming Peng, Associate professor, Beijing Tiantan Hospital
    ClinicalTrials.gov Identifier:
    NCT03081429
    Other Study ID Numbers:
    • 2017-3-10
    First Posted:
    Mar 16, 2017
    Last Update Posted:
    Sep 14, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stroke
    Postoperative Cognitive Complications
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Sep 14, 2021