跳至主要内容
临床试验/NCT06754956
NCT06754956招募中不适用

Imaging Study of Intracranial and Extracranial Arterial Atherosclerotic Plaques Using 3.0T and 5.0T MRI: A Prospective Self-Controlled Study

Shanghai Jiao Tong University Affiliated Sixth People's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Comparison of the Accuracy of Clinical Event-Based Definition of Plaque Vulnerability Assessed by 5.0T and 3.0T HR-VWI.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Comparison of the Accuracy of Clinical Event-Based Definition of Plaque Vulnerability Assessed by 5.0T and 3.0T HR-VWI.

时间窗: immediately after HR-VWI injection

次要结局

  • 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)

研究者

发起方
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yueqi Zhu

MD

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

研究点 (1)

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