Imaging of Intracranial and Extracranial Arterial Atherosclerotic Plaques Using Different Field S… (NCT06754956) | Clinical Trial Compass
RecruitingNot Applicable
Imaging of Intracranial and Extracranial Arterial Atherosclerotic Plaques Using Different Field Strength MRIs
China100 participantsStarted 2025-01-10
Plain-language 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.
Who can participate
Age range
18 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of the Accuracy of Clinical Event-Based Definition of Plaque Vulnerability Assessed by 5.0T and 3.0T HR-VWI.
Timeframe: immediately after HR-VWI injection
Trial details
NCT IDNCT06754956
SponsorShanghai Jiao Tong University Affiliated Sixth People's Hospital