Imaging of Intracranial and Extracranial Arterial Atherosclerotic Plaques Using Different Field Strength MRIs

Not Applicable

Recruiting

• Conditions: High Resolution Vessel Wall Imaging; Intracranial Atherosclerotic Stenosis, ICAS; Arteriosclerosis

• Registration Number: NCT06754956
• Lead Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Brief Summary

Atherosclerotic stenosis of the carotid and intracranial arteries is one of the leading causes of ischemic cerebrovascular events worldwide. Among these, intracranial atherosclerotic stenosis has an incidence rate of up to 46.6% in patients with ischemic stroke or transient ischemic attack (TIA) in China. The continuous advancement of high-resolution vascular wall imaging (HR-VWI) technology has enabled multi-dimensional imaging of the arterial walls of both intracranial and extracranial vessels. By suppressing intravascular flow, this technique allows clear visualization of the vascular wall morphology and signal characteristics, as well as the identification of plaque composition and assessment of vulnerable plaque features. However, due to the smaller size of intracranial atherosclerotic plaques, the image quality and effectiveness of current 3.0T high-resolution magnetic resonance imaging (MRI) are influenced by hardware and software limitations, as well as imaging parameters, making it difficult to accurately perform qualitative and quantitative analysis of intracranial and extracranial plaques. The advent of ultra-high field 5.0T MRI overcomes the limitations of 3.0T MRI in imaging, significantly improving the signal-to-noise ratio and allowing for clearer visualization of the signal characteristics of the arteria.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-24
• Study First Submitted QC: 2024-12-31
• Study First Posted: 2025-01-01
• Last Update Submitted: 2025-01-09
• Study Start: 2025-01-10
• Last Update Posted: 2025-01-13
• Primary Completion: 2027-09-23
• Study Completion: 2027-12-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age ≥ 18 years;
• Moderate to severe intracranial or extracranial arterial stenosis (stenosis degree: 50% to 99%, confirmed by CTA, MRA, or DSA);
• Written informed consent signed by the patient or their legal representative.

Exclusion Criteria

• Non-atherosclerotic intracranial arterial stenosis, such as dissection or moyamoya disease;
• Contraindications to MRI, such as claustrophobia or presence of a cardiac pacemaker;
• Allergy to gadolinium-based contrast agents;
• Poor MRI image quality preventing analysis;
• Abnormal liver or kidney function;
• History of any prior endovascular treatment;
• Presence of implants posing potential safety risks in 5.0T MRI, such as non-removable metallic dental prostheses, stents, or other metallic implants.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Comparison of the Accuracy of Clinical Event-Based Definition of Plaque Vulnerability Assessed by 5.0T and 3.0T HR-VWI.	immediately after HR-VWI injection

Secondary Outcome Measures

Name	Time	Method
Comparison of image quality of 5.0T and 3.0T HR-VWI.	immediately after HR-VWI injection
Comparison of clinicians' visual scale for 5.0T and 3.0T HR-VWI.	immediately after HR-VWI injection	The clinicians' visual scale is a four-point scale. 1 for inadequate, 2 for adequate, 3 for good, 4 for excellent. In detail, excellent rated images meant clear vessel wall delineation for entire boundary. Good images showed good vessel wall delineation with only small part of obscure/invisible boundary. Adequate rated images stood for reasonable image quality on vessel wall visualization involving some part but less than a quadrant of obscure/invisible boundary. Inadequate images were those in which most of the vessel wall boundaries could not be seen.

Trial Locations

Locations (1)

Shanghai Sixth People's Hospital, Shanghai,200023; 🇨🇳 Shanghai, China