Development and Validation of the Prediction Model for Cognitive Impairment

Sponsor
Shenzhen Second People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05465980
Collaborator
(none)
496
25

Study Details

Study Description

Brief Summary

According to the "Chinese Stroke Report" released in 2020, the incidence of stroke in China is 1114.8/100,000, acute ischemic stroke (AIS) accounts for 70% to 80% of the total number of stroke population, and elderly stroke patients are up to 2/3. About 1/3 of stroke patients would experience post-stroke cognitive impairment (PSCI), which seriously affected patients' quality of life and survival time, and increases disease and economic burden. Therefore, early identification, assessment, prevention and intervention of PSCI, and improvement of patients' quality of life and prognosis have become the focus of clinical research.

This is a prospective cohort study. We intend to: (1) continuously collect elderly AIS patients who will be admitted to the Department of Neurology, The Department of Rehabilitation and the Department of Gerontology of Shenzhen Second People's Hospital from 2022 year to 2024 year; (2) collect baseline and follow-up data, and build a prediction model for cognitive impairment in elderly AIS patients; (3) internal validation using Bootstrap model; (4) collect the data of the elderly AIS patients who will be admitted to Shenzhen Longhua District People's Hospital andShenzhen Longgang Central Hospital, and conduct external validation; (5) evaluate the predictive efficacy of the model.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study consists of two parts. The first part is to develop a predictive model for cognitive impairment in elderly patients with acute ischemic stroke. Continuously collect the baseline data and follow-up data of elderly AIS patients admitted to the Shenzhen Second People's Hospital from September 2022 to December 2023, including general demographic data, laboratory examination indicators, imaging indicators and assessment scales. Take the occurrence of PSCI as the dependent variable and the risk factors of PSCI in elderly AIS patients will be analyzed. Multivariate Cox regression will be used to develop a prediction model for cognitive impairment in elderly AIS patients.

    The second part is to do clinical evaluation of prediction model of cognitive impairment in elderly patients with acute ischemic stroke. Bootstrap method will be used for internal validation of the model. Continuously collect the data of elderly AIS patients from January 2024 to December 2024 from the other two hospitals in Guangdong Province, China. Externally validate the model and evaluate the clinical application effect of PSCI prediction model in elderly AIS patients using C-index, reclassification index, calibration curve, time-dependent ROC curve and other indicators. Finally, the model is presented by nomogram.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    496 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Development and Validation of the Prediction Model for Cognitive Impairment in Elderly Patients After Acute Ischemic Stroke
    Anticipated Study Start Date :
    Sep 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Sep 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. MMSE score [From July 1, 2022 to May 31, 2025]

      The primary outcome will be assessed by the Mini-mental State Examination(MMSE) scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Patients age 60 years or older.

    2. Stroke occurring within 7 days.

    3. Meet the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Acute ischemic Stroke 2018.

    4. Informed consent.

    Exclusion Criteria:
    1. Incomplete main clinical data;

    2. Patients with transient ischemic attack;

    3. Patients had cognitive dysfunction before enrollment.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shenzhen Second People's Hospital

    Investigators

    • Principal Investigator: Xiaohua Xie, master, Shenzhen Second People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shenzhen Second People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05465980
    Other Study ID Numbers:
    • 20223357018
    First Posted:
    Jul 20, 2022
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 20, 2022