Development and Validation of the Prediction Model for Cognitive Impairment
1 other identifier
observational
496
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2022
CompletedFirst Posted
Study publicly available on registry
July 20, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedJuly 20, 2022
June 1, 2022
1.3 years
July 18, 2022
July 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
MMSE score
The primary outcome will be assessed by the Mini-mental State Examination(MMSE) scale
From July 1, 2022 to May 31, 2025
Eligibility Criteria
The elderly patients with acute ischemic stroke.
You may qualify if:
- Patients age 60 years or older.
- Stroke occurring within 7 days.
- Meet the diagnostic criteria of Chinese Guidelines for the Diagnosis and Treatment of Acute ischemic Stroke 2018.
- Informed consent.
You may not qualify if:
- Incomplete main clinical data;
- Patients with transient ischemic attack;
- Patients had cognitive dysfunction before enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaohua Xie, master
Shenzhen Second People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2022
First Posted
July 20, 2022
Study Start
September 1, 2022
Primary Completion
December 31, 2023
Study Completion
September 30, 2024
Last Updated
July 20, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share