Imaging of Intracranial and Extracranial Arterial Atherosclerotic Plaques Using Different Field Strength MRIs

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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) .

Первичные конечные точки

• Comparison of the Accuracy of Clinical Event-Based Definition of Plaque Vulnerability Assessed by 5.0T and 3.0T HR-VWI. [Срок оценки: immediately after HR-VWI injection]

Вторичные конечные точки (2)

• Comparison of image quality of 5.0T and 3.0T HR-VWI. [Срок оценки: immediately after HR-VWI injection]
• Comparison of clinicians' visual scale for 5.0T and 3.0T HR-VWI. [Срок оценки: immediately after HR-VWI injection]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Shanghai Sixth People's Hospital, Shanghai,200023 — Шанхай

Идентификаторы

NCT: NCT06754956 · Imaging-SISTER study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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