Prediction Model for Chronic Intracranial Arterial Occlusion With Radiomic Features

NCT06066593 | Unknown DMC

• 1 other identifier: 2023BJYYEC-239-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Stroke, Ischemic; Stroke Hemorrhagic

Keywords

Chronic intracranial arterial occlusion; Multimodal CT; Radiomics; Machine Learning; Deep Learning

Outcome Measures

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.

  1 year

Study Arms (3)

Ischemic Stroke

MRI suggests a new cerebral infarction.

Hemorrhagic Stroke

CT suggests a new cerebral hemorrhage.

Asymptomatic Group

Without new infarction or hemorrhage

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Hospital: lead
• Beijing Tiantan Hospital: collaborator
• Chinese Academy of Sciences: collaborator

Study Sites (2)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dong Zhang, Doctor

  Beijing Hospital

  STUDY CHAIR

Central Study Contacts

Shaosen Zhang, Doctor

CONTACT

18611284839; longyoubafang@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 4, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 31, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-09

Locations

CN (2)