An interventional study of The patient will receive two intravenous injections of the same gadoterate meglumine contrast agent. in High Resolution Vessel Wall Imaging, Intracranial Atherosclerotic Stenosis, ICAS and Arteriosclerosis, sponsored by Shanghai Jiao Tong University Affiliated Sixth People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2025-06-29.
Sponsored by Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Not applicable, Interventional, and Diagnostic
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.
157 studies on the registry are indexed under Arteriosclerosis; 18 are open to participants now.
This study's planned enrollment of 100 is close to the median of 109 across 104 interventional studies indexed under Arteriosclerosis.
Browse Arteriosclerosis studies →Shanghai Jiao Tong University Affiliated Sixth People's Hospital is the lead sponsor of 40 studies on the registry; 22 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: The 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) .
Comparison of the Accuracy of Clinical Event-Based Definition of Plaque Vulnerability Assessed by 5.0T and 3.0T HR-VWI.
Time frame: immediately after HR-VWI injection
Comparison of image quality of 5.0T and 3.0T HR-VWI.
Time frame: immediately after HR-VWI injection
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.
Time frame: immediately after HR-VWI injection
Plan to share: No
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Started Jan 2025 (actual). Primary completion is estimated for Sep 2027, 32 months after the start.
Of 29 interventional studies with no phase under Arteriosclerosis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's planned 32 months is above that.
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Shanghai Jiao Tong University Affiliated Sixth People's Hospital