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Completed

NCT Number: NCT06796283

Research on AIS Recurrence Risk Prediction Model Using XGBoost Combined With Convolutional Neural Network Algorithm

The purpose of this observational study is to construct a recurrence risk prediction model for ischemic stroke within 1, 3, 6, and 12 months using XGBoost combined with Convolutional Neural Network (CNN) algorithm.

Method: Follow up was conducted on the study subjects at 1, 3, 6, and 12 months after discharge.

Follow up primary outcome: Whether the study subjects experienced recurrent stroke events.

Secondary outcome: Improved Rinkin score.

Collect information on research subjects:

It includes demographic data, physical examination, medical history, imaging images, medication use, scale scores, CYP2C19 genotype test results, laboratory tests, and other complex multidimensional data.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330008, China

About this study

This project conducts a one-year follow-up on the enrolled subjects (patients with ischemic stroke) to observe the recurrence and modified Rankin scores after discharge. Combining complex multidimensional data such as demographic information, physical examination, medical history, imaging images, medication status, NIHSS scale scores, Glasgow Coma Scale scores, CYP2C19 genotype test results, and laboratory examinations of the subjects; Convolutional Neural Networks (CNNs) are used to segment lesions and extract features from the subjects' imaging images; Cox regression models are employed to obtain factors influencing recurrence; a prediction model for the risk of recurrence within 1, 3, 6, and 12 months for ischemic stroke is constructed using the XGBoost algorithm combined with Convolutional Neural Networks. The exploration aims to provide new insights and methods for the prevention and control of major chronic diseases by evaluating the effectiveness of XGBoost in predicting the risk of ischemic stroke recurrence at different times.

  • Inclusion Criteria:
  • 18-85 years old;
  • Diagnosed with ischemic stroke or transient ischemic attack (diagnosis meets the criteria established by the Cerebrovascular Disease Group of the Neurology Branch of the Chinese Medical Association in 2014);
  • During the acute phase of onset (2 weeks);
  • Voluntarily participate and sign an informed consent form.
  • Exclusion criteria:
  • Cancer patients;
  • Cardiogenic infarction, cerebral infarction of other causes, and cerebral infarction of unknown causes;
  • Patients with hemorrhagic stroke, mixed stroke, and tumor stroke;
  • Merge with severe heart, lung, and liver system diseases;
  • Researchers identify patients with poor compliance and inability to complete long-term follow-up;
  • Patients currently participating in any clinical trials related to investigational drugs or medical devices.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18-85 years
  • Diagnosed with ischemic stroke or transient ischemic attack (diagnosis in accordance with the standards set by the Cerebrovascular Disease Group of the Neurology Branch of the Chinese Medical Association in 2014)
  • Within the acute phase of the illness (within 2 weeks)
  • Voluntarily participates and signs an informed consent form

Exclusion criteria

  • Patients with cancer
  • Patients with cardiogenic infarction, other causes of cerebral infarction, or cryptogenic cerebral infarction
  • Patients with hemorrhagic stroke, mixed stroke, and tumor stroke
  • Patients with severe heart, lung, or liver system diseases
  • Patients judged by the researcher to have poor compliance and unable to complete long-term follow-up
  • Patients currently participating in any clinical trials related to investigational drugs or medical devices

Treatment and study plan

Primary outcomes

  1. Recurrent ischemic stroke,

    Time frame: April 6th, 2021- March 12th, 2024

    Follow up was conducted on the study subjects at 1, 3, 6, and 12 months after discharge, with the main outcome being whether the study subjects experienced stroke recurrence events

Secondary outcomes

  1. modified Rankin score

    Time frame: April 6th, 2021- March 12th, 2024

    Follow up was conducted on the study subjects at 1, 3, 6, and 12 months after discharge, with the secondary outcome being the modified Rinkin score.Improved Rinkin Scale:

    Completely asymptomatic (0 points). Despite symptoms, there is no obvious functional impairment and the ability to complete all daily work and life tasks (1 point).

    Mild disability, unable to complete all pre illness activities, but able to take care of daily affairs without assistance (2 points).

    Moderate disability, requiring partial assistance, but able to walk independently (3 points).

    Moderate to severe disability, unable to walk independently, requiring assistance from others in daily life (4 points).

    Severe disability, bedridden, urinary incontinence, and complete dependence on others in daily life (5 points).

    The higher the score, the worse the participant's neurological function recovery.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Nanchang University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jan 28, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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