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RecruitingNCT06066593Updated Oct 4, 2023

Prediction Model for Chronic Intracranial Arterial Occlusion With Radiomic Features

An observational study in Stroke, Ischemic and Stroke Hemorrhagic, sponsored by Beijing Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-04.

Sponsored by Beijing Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Chronic intracranial arterial occlusion is associated with a "bidirectional stroke risk," with a significantly increased risk of both ischemic stroke and cerebral hemorrhage. Currently, Western CTAP products, in combination with clinical expertise, offer some predictive value for assessing the risk of ischemic events by evaluating compensatory pathways and overall perfusion in chronic intracranial arterial occlusion. However, there is limited support for assessing the risk of hemorrhagic events.

Our proposed project aims to address a significant scientific challenge: the precise assessment of long-term stroke risk in asymptomatic patients with chronic intracranial arterial occlusion using a machine learning-based approach. The rapidly advancing field of machine learning provides a rich set of solutions for tackling this problem. In this project, we intend to develop a deep learning-based segmentation model for key brain regions using multimodal CT scans. Subsequently, we will automate the extraction of radiomic features and CT perfusion parameters, followed by the application of machine learning techniques to construct a stroke risk prediction model tailored for patients with chronic intracranial arterial occlusion.

Read the detailed description
  1. Establishment of a Brain Segmentation Model for Key Brain Regions Based on Multimodal CT

    The establishment of a brain segmentation model for key brain regions based on multimodal CT is one of the core components of this research. The project plans to use advanced algorithms such as U-Net and Transformer as the foundation to develop a model for automatically segmenting key brain regions in CT images. These key brain regions include the basal ganglia, frontal lobe, temporal lobe, parietal lobe, and others. The development of the automatic segmentation model consists of two main parts: training and validation. Retrospective cohort data from this research are used to constitute the training set. Specific brain regions are manually annotated to serve as training materials for the model. Parameter tuning and internal validation are conducted to achieve satisfactory training results. Prospective cohort data from this research form an independent validation set used for external validation of the model. The performance evaluation criteria for the model include the DICE coefficient and loss value.

  2. Exploration of Core Neuroimaging Features Related to Stroke in Patients with Chronic Intracranial Arterial Occlusion

    Using masks generated by the automatic segmentation model, this study intends to extract radiomic information and CT perfusion parameters of specific brain regions through a self-designed automated workflow. These features will be used to construct a machine learning predictive model for stroke risk in patients with chronic intracranial arterial occlusion. To select the most effective features for stroke prediction, a feature selection and dimensionality reduction process is required. This study plans to use L1 regularization to reduce the dimensionality of the standardized data, aiming to optimize the ROC area under the curve (AUC). Thus, it is possible to explore and refine core neuroimaging features related to stroke in patients with intracranial arterial occlusion, analyze their correlation with stroke, and use them for subsequent model construction.

  3. Construction and Validation of a Stroke Prediction Model Based on Core Neuroimaging Features of Key Brain Regions

The construction and validation of the prediction model are divided into training and validation phases. The training data are collected from the training cohort and internally validated using cross-validation. The prospective cohort remains an independent validation set for external validation of the model. Model construction begins with testing basic machine learning models' performance. By analyzing the performance of these basic models, the architecture of an ensemble learning model is designed and constructed. Finally, the ensemble learning model is validated. The primary performance metric for the model is the area under the ROC curve (AUC), and additional evaluation metrics such as accuracy, recall, precision, and F1 score are used for supplementary assessment of performance.

02

Conditions studied

  • Stroke, Ischemic
  • Stroke Hemorrhagic

Keywords

  • Chronic intracranial arterial occlusion
  • Multimodal CT
  • Radiomics
  • Machine Learning
  • Deep Learning
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Beijing Hospital is the lead sponsor of 51 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Training Cohort Selection:

600 patients with chronic intracranial arterial occlusion who had been confirmed to have experienced new-onset intracranial stroke through cranial MRI, with 200 experienced ischemic strokes, 200 experienced hemorrhagic strokes, and 200 asymptomatic patients.

Test Cohort Selection:

400 patients with chronic intracranial arterial occlusion who presented with either no symptoms or isolated TIAs.

Inclusion criteria

  • Diagnosed with chronic intracranial arterial occlusion.
  • Asymptomatic or with a history of only transient ischemic attacks (TIAs).
  • The age of the patient falls within the range of 18 to 80 years old.
  • Willing to undergo both perfusion CT scans and magnetic resonance imaging (MRI).

Exclusion criteria

Exclusion Criteria:

  • Acute intracranial arterial occlusive disease.
  • History of either ischemic or hemorrhagic stroke.
  • Allergies to contrast agents or conditions such as claustrophobia that prevent completion of imaging data acquisition.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Ischemic Stroke

    MRI suggests a new cerebral infarction.

  • Hemorrhagic Stroke

    CT suggests a new cerebral hemorrhage.

  • Asymptomatic Group

    Without new infarction or hemorrhage

06

What researchers measure

Primary outcomes

  1. Stroke

    The patient cohort requires the collection of both CT and MRI imaging data, including various modalities: CT Imaging: CT Plain Scan, CT Angiography, CT Perfusion MRI Imaging: T1-Weighted Imaging, T2-Weighted Imaging, DWI, FLAIR Follow-up evaluations should be conducted annually to record the occurrence of either hemorrhagic or ischemic stroke events. This involves monitoring and documenting whether any stroke events (hemorrhagic or ischemic) have occurred in the patient cohort during the follow-up period.

    Time frame: 1 year

07

Study locations

2 of 2 sites recruiting
  • Beijing Tiantan Hospital
    Beijing, Beijing 100070, China
    Recruiting
  • Beijing Hospital
    Beijing, Beijing 100730, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — The data that support the findings of this study are available from the corresponding author upon reasonable request.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06066593
Lead sponsor
Beijing Hospital
Collaborators
Beijing Tiantan Hospital, Chinese Academy of Sciences
Responsible party
Sponsor
First posted
Oct 4, 2023
Start date
Aug 1, 2023
Primary completion
Aug 1, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Oct 4, 2023

Study contacts

Shaosen Zhang, Doctor
Contact
longyoubafang@hotmail.com
18611284839
Dong Zhang, Doctor
study chair · Beijing Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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