About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Sequential
Treatments tested in this trial
The patient will receive two intravenous injections of the same gadoterate meglumine contrast agent.
DeviceEach 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) .
Treatment groups
Trial outcomes
Primary outcomes
Comparison of the Accuracy of Clinical Event-Based Definition of Plaque Vulnerability Assessed by 5.0T and 3.0T HR-VWI.
Secondary outcomes
Comparison of image quality of 5.0T and 3.0T HR-VWI.
Comparison of clinicians' visual scale for 5.0T and 3.0T HR-VWI.
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.
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