Arteriosclerosis, High Resolution Vessel Wall Imaging, Intracranial Atherosclerotic Stenosis, ICAS
Conditions
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.
Interventions
DEVICEThe patient will receive two intravenous injections of the same gadoterate meglumine contrast agent.
Each patient will undergo two different field strength HR-VWIs with enhancement, and on each occasion the patient will be injected with contrast DOTAREM (gadoterate meglumine) .
Sponsors
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactYueqi Zhu
Outcome results
None listed