Ischemic StrokeNCT06796283
Research on AIS Recurrence Risk Prediction Model Using XGBoost Combined With Convolutional Neural Network Algorithm
An observational study of Ischemic Stroke, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- How many people
- 2,628 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ischemic stroke patients treated in hospitals who meet the inclusion and exclusion criteria for the project
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008
About this study
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.
Read the detailed description
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.
- Conditions
- Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: April 6th, 2021- March 12th, 2024
Secondary outcomes (1)
modified Rankin score
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.
Measured: April 6th, 2021- March 12th, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start26 Apr 2021
- Primary completion4 Mar 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yingping Y Yi, Principal investigator, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796283
- Sponsor's protocol ID
- 2021efyB03
- Status last verified
- Feb 2025
- First submitted
- 13 Jan 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39631660
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on AIS Recurrence Risk Prediction Model Using XGBoost Combined With Convolutional Neural Network Algorithm
- ClinicalTrials.gov ID
- NCT06796283
- Acronym / sponsor ID
- 2021efyB03
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,628 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ischemic stroke patients treated in hospitals who meet the inclusion and exclusion criteria for the project
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
modified Rankin score
Time frame: April 6th, 2021- March 12th, 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Results publication: PubMed 39631660Liu 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.
- Explore deep - learning - based infarct lesion segmentation in AIS patients' brain MRI, radiomics - based 1 - year recurrence prediction, and develop a combined model for accurate AIS recurrence predictionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yingping Y Yi principal investigator
Second Affiliated Hospital of Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent ischemic stroke, (time frame: April 6th, 2021- March 12th, 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06796283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.