NCT06796283

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,628

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

1.9 years

First QC Date

January 13, 2025

Last Update Submit

February 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Recurrent ischemic stroke,

    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

    April 6th, 2021- March 12th, 2024

Secondary Outcomes (1)

  • modified Rankin score

    April 6th, 2021- March 12th, 2024

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ischemic stroke patients treated in hospitals who meet the inclusion and exclusion criteria for the project

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330008, China

Location

Related Publications (1)

  • Liu J, Li J, Wu Y, Luo H, Yu P, Cheng R, Wang X, Xian H, Wu B, Chen Y, Ke J, Yi Y. Deep learning-based segmentation of acute ischemic stroke MRI lesions and recurrence prediction within 1 year after discharge: A multicenter study. Neuroscience. 2025 Jan 26;565:222-231. doi: 10.1016/j.neuroscience.2024.12.002. Epub 2024 Dec 2.

Related Links

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • yingping Y Yi

    Second Affiliated Hospital of Nanchang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 28, 2025

Study Start

April 26, 2021

Primary Completion

March 4, 2023

Study Completion

December 31, 2024

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations